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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK115687-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.
The length of this study, including screening is approximately 24 months. Patients at Bariatric Surgery Clinics will be recruited for this study. Both patients that decide to undergo bariatric surgery, and those that do not undergo surgery will be enrolled. Patients will be randomized to either a high intensity interval training (HIIT) or standard exercise regimen after eligibility is confirmed and the baseline visit is complete. All patients will complete follow-up appointments at 3 month, 12 months and 24 months. Patients that are randomized to the HIIT program will compete 2 supervised and 1 unsupervised training sessions a week for 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery/HIIT | Active Comparator | Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. |
|
| Bariatric Surgery/Routine Exercise | Active Comparator | Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. |
|
| No Bariatric Surgery/HIIT | Active Comparator | Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. |
|
| No Bariatric Surgery/Routine Exercise | Active Comparator | Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training (HIIT) | Other | Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh. | Baseline, 3 months, 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the distal leg. | Baseline, 3 months, 12 months and 24 months |
| Corneal Confocal Microscopy (CCM) - Fiber Density |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian C Callaghan, MD, MS | University of Michigan, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39394845 | Derived | Reynolds EL, Koenig F, Watanabe M, Kwiatek A, Elafros MA, Stino A, Henderson D, Herrmann DN, Feldman EL, Callaghan BC. Comparison of intraepidermal nerve fiber density and confocal corneal microscopy for neuropathy. Ann Clin Transl Neurol. 2024 Dec;11(12):3115-3124. doi: 10.1002/acn3.52218. Epub 2024 Oct 12. |
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140 participants were randomized to one of the four arms. Prior to randomization, participants had a screening visit, pre-baseline visit, and baseline visit to confirm eligibility. If participants qualified for the study, they were randomized and moved on with the study.
Participants were recruited from Bariatric Surgery clinics in Ann Arbor and Detroit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bariatric Surgery/HIIT | High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months. Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care. |
| FG001 | No Bariatric Surgery/HIIT | High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months. Procedure/Surgery: None |
| FG002 | Bariatric Surgery/Routine Exercise | Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care. |
| FG003 | No Bariatric Surgery/Routine Exercise | Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). Procedure/Surgery: None |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| ||||||||||||||||||
| 3 Months |
| |||||||||||||||||||
| 12 Months |
| |||||||||||||||||||
| 24 Months |
|
Data was collected for participants who were randomized in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | No Bariatric Surgery/HIIT | Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | fibers/mm | Baseline, 3 months, 12 months and 24 months |
|
2 years
Participants who withdrew from the study were not tracked after their withdrawal date
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bariatric Surgery/HIIT | High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months. Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection at Skin Biopsy Site | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Callaghan, MD | University of Michigan | 7349367183 | Bcallagh@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2020 | Aug 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2025 | Aug 28, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2024 | Jun 2, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Patients will be assigned to one of 4 arms, bariatric surgery/HIIT, bariatric surgery/routine exercise, no bariatric surgery/HIIT, no bariatric surgery/routine exercise.
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The neuropathy outcomes assessors will be blinded to the exercise protocol that the patients are randomized to and the surgical status for the duration of the study.
| Routine Exercise | Other | Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). |
|
| Bariatric surgery | Procedure | Patients will undergo bariatric surgery as part of their routine care |
|
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology.
Corneal Nerve Fiber Density are quantified by fibers/mm2, a higher number represents a higher density of fibers. Lower numbers indicate worse neuropathy.
| Baseline, 3 month, 12 months and 24 months |
| Corneal Confocal Microscopy (CCM) - Branch Density | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Branch Density are quantified by branches/mm2, a higher number represents a higher density of branches. Lower numbers indicate worse neuropathy. | Baseline, 3 month, 12 months and 24 months |
| Corneal Confocal Microscopy (CCM) - Fiber Length | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Length are quantified by mm/mm2, a higher number represents a higher total length of fibers. Lower numbers indicate worse neuropathy . | Baseline, 3 month, 12 months and 24 months |
| Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Tortuosity Coefficient represents the total tortuosity (twisting/bending of nerves). As a coefficient the value is unitless, a higher value represents greater tortuosity. Lower numbers indicate worse neuropathy. | Baseline, 3 month, 12 months and 24 months |
| 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Mean Deviation is presented below. Mean deviation is the average difference from normal expected value in the patients' particular age group. Lower values indicate more visual deficit. Higher values indicate fewer visual deficit. | Baseline, 3 month, 12 months and 24 months |
| 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Foveal sensitivity is presented below. Foveal sensitivity is the measurement of the fovea's light detection ability. Lower values suggest visual field deficits. | Baseline, 3 month, 12 months and 24 months |
| 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Pattern SD (PSD) is presented below. PSD provides information about localized loss. A higher PSD indicates a non-uniform sensitivity loss and visual field deficit. | Baseline, 3 month, 12 months and 24 months |
| Retinal Fundus Photography | As assessed by fundus photographs, participants were identified as either having retinopathy or not having retinopathy. Data is shown as number of people with retinopathy at a particular study visit. | Baseline, 3 month, 12 months and 24 months |
| Nerve Conduction Study (NCS) - Latency | Latency measures the time in millisecond between stimulation and the recording electrode. Was performed on sural, peroneal, and tibial nerves. No response and abnormal values indicate neuropathy.
| Baseline and 24 months |
| Nerve Conduction Study (NCS) - Motor Amplitude | Amplitude measures the height of electrical signal (waveform) in millivolts produced by the stimulated motor nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy.
| Baseline and 24 months |
| Nerve Conduction Study (NCS) - Sensory Amplitude | Amplitude measures the height of electrical signal (waveform) in microvolts produced by the stimulated sensory nerve. Was performed on sural nerve. No response and abnormal values indicate neuropathy. * Sural: 0 - No response, <4 - Abnormal | Baseline and 24 months |
| Nerve Conduction Study (NCS) - CV | Conduction velocity (V) measures the speed (m/s) at which the electrical impulse travels along the nerve. Was performed on peroneal nerves. No response and abnormal values indicate neuropathy. Abnormal values are <36 or 39, depending on whether certain criteria applied to the participant. Data was not analyzed separately. | Baseline and 24 months |
| Nerve Conduction Study (NCS) - F Wave Index | F wave index measures the time in millisecond between stimulation at a distal (near the muscle) point and for the stimulus to travel to the spinal cord and back, allowing to assess the entire length of the nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy.
| Baseline and 24 months |
| Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Deep breathing/exhalation to inhalation (E:I) ratio were evaluated using PS monitor software. Values < 1 are abnormal, indicative of cardiovascular autonomic neuropathy | Baseline and 24 months |
| Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Postural change-30:15 ratio was evaluated using PS monitor software. Values < 1 are abnormal, indicative of cardiovascular autonomic neuropathy | Baseline and 24 months |
| Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Valsalva ratio was evaluated using PS monitor software. Values <= 1.10 are abnormal, indicative of cardiovascular autonomic neuropathy | Baseline and 24 months |
| Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | Toronto definition of probable neuropathy is having at least 2 out of 3 of the following: abnormal sensory examination, reflexes, and patient-reported symptoms. Data is reported as number of participants who, under the Toronto definition, were identified as having probable polyneuropathy. | 24 months |
| Michigan Neuropathy Screening Instrument (MNSI) | MNSI questionnaire is scored from 0-15, score > 4 indicate neuropathy, higher scores indicate worse neuropathy. A score of 1 point is given for answers of "yes" for questions 1-6, 8-12, 14, and 15 and "no" for questions 7 and 13. | Baseline, 3 month, 12 months and 24 months |
| Michigan Neuropathy Screening Instrument (MNSI) - Exam | MNSI exam is scored from 0-8, score >= 2.5 indicate neuropathy. Higher scores indicate worse neuropathy. | Baseline, 3 month, 12 months and 24 months |
| Michigan Neuropathy Screening Instrument (MNSI) - Index | The Michigan Neuropathy Screening Instrument (MNSI) index is a weighted composite score computed using the sum of the b-coefficients for all items within the MNSI questionnaire (15 questions) and MNSI exam (4 physical/visual exam). Range: -0.93, 7.39 Values > 2.5407 are indicative of clinical neuropathy | Baseline, 3 month, 12 months and 24 months |
| Utah Early Neuropathy Score (UENS) | UENS is a composite score with five sections measuring multiple clinical measures of nerve injury. Sections are scored separately for each side (Right vs Left), and the total score is the sum across everything. Range: 0-42, higher score represents more severe polyneuropathy. | Baseline, 3 month, 12 months and 24 months |
| Modified Toronto Neuropathy Score (mTNS) | mTNS is a scale of 0-33 that measures neuropathy symptoms and exam findings. Higher scores indicate more severe polyneuropathy. | Baseline, 3 month, 12 months and 24 months |
| Survey of Autonomic Symptoms (SAS) | SAS evaluates the presence and magnitude of autonomic symptoms. Total impact score ranges from 0-60 (or up to 55 for participants to whom certain criteria did not apply). Higher score indicates worse autonomic neuropathy | Baseline, 3 month, 12 months and 24 months |
| Diabetic Neuropathy Score (DNS) | DNS is a questionnaire of neuropathy symptoms. Score ranges 0-4, >/=1 indicates polyneuropathy. 0 indicates no polyneuropathy. | Baseline, 3 month, 12 months and 24 months |
| Short Form McGill Pain Questionnaire | Sum of the sensory score (0-30) and affective score (0-15) for a total score of 0-45. A higher score represents greater pain present. | Baseline, 3 months, 12 months, 24 months |
| Numerical Rating Scale for Pain | Participant reported pain scale with range 0-10, higher score indicates more pain. | Baseline, 3 months, 12 months, 24 months |
| Neuropathy Quality of Life (NeuroQOL) | Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life. | Baseline, 3 months, 12 months, and 24 months |
| 8 Foot Get Up and Go Test | This test measures in seconds how long it takes the participant to stand up from a seated position, walk around a cone places 8 feet away, and return to the chair and sit down. Less time indicates better speed, agility, and balance when moving. | Baseline, 3 months, 12 months, and 24 months |
| Berg Balance Scale | Berg Balance Scale measures participants' ability to balance and avoid falls. Scores range from 0-56, higher score indicates less likely to fall. | Baseline, 3 months, 12 months, and 24 months |
| Modified Falls Efficacy Scale - Fall Evaluation | Patient response indicating if they have fallen in the last year. Data is shown as number of people who have fallen in the last year. | Baseline, 3 months, 12 months, and 24 months |
| Neurothesiometer | Neurothesiometer is placed on the bottom of the great toe, and slowly increased until participant reports they can feel the vibration. The greater the microns, the less feeling the participant has, suggestive of worse sensory function. Value > 25 Microns is indicative of neuropathy. There is no known maximum range. Lower values indicate better sensory function. | Baseline, 3 months, 12 months, and 24 months |
| NIH Toolbox Cognitive Battery | NIH Toolbox Cognition Fluid (Range: 0-100) - Composite score derived as an average across five cognitive domains. It's a fully adjusted T-score comparing the participant to a nationally representative sample, stratified by age and other demographics. Individual domain scores are fully adjusted T score with range 0-100 and measures the following-
A T-score of 50 represents the population mean. A score of 60 indicates that the participant is 1 SD above the national average for individuals with similar demographic characteristics Higher scores reflect better cognitive functionality. No set clinical threshold, scores above mean indicate above average cognition for a given age group. | Baseline and at 24 months |
| Rey Auditory Verbal Learning Test | Used to evaluate verbal learning and memory using a list of 15 unrelated words presented to the participant over repeat trial. Includes 3 independent scales:
No set clinical threshold, scores above mean indicate above average cognition for a given age group. | Baseline and at 24 months |
| Withdrawal by Subject |
|
| Driving Distance/Travel |
|
| Family Obligations |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED | Anyone who did not complete visit 6 was considered withdrawn after visit 5. |
|
| NOT COMPLETED |
|
| Bariatric Surgery/Routine Exercise |
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. |
| BG002 | Bariatric Surgery/HIIT | Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. |
| BG003 | No Bariatric Surgery/Routine Exercise | Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Bariatric Surgery/Routine Exercise | Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care |
| OG002 | No Bariatric Surgery/HIIT | Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months. |
| OG003 | No Bariatric Surgery/Routine Exercise | Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). |
|
|
|
| Secondary | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the distal leg. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | fibers/mm | Baseline, 3 months, 12 months and 24 months |
|
|
|
|
| Secondary | Corneal Confocal Microscopy (CCM) - Fiber Density | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Density are quantified by fibers/mm2, a higher number represents a higher density of fibers. Lower numbers indicate worse neuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | fibers/mm^2 | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | Corneal Confocal Microscopy (CCM) - Branch Density | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Branch Density are quantified by branches/mm2, a higher number represents a higher density of branches. Lower numbers indicate worse neuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | branches/mm^2 | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | Corneal Confocal Microscopy (CCM) - Fiber Length | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Length are quantified by mm/mm2, a higher number represents a higher total length of fibers. Lower numbers indicate worse neuropathy . | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | mm/mm2 | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Tortuosity Coefficient represents the total tortuosity (twisting/bending of nerves). As a coefficient the value is unitless, a higher value represents greater tortuosity. Lower numbers indicate worse neuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | Coefficient | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Mean Deviation is presented below. Mean deviation is the average difference from normal expected value in the patients' particular age group. Lower values indicate more visual deficit. Higher values indicate fewer visual deficit. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | dB | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Foveal sensitivity is presented below. Foveal sensitivity is the measurement of the fovea's light detection ability. Lower values suggest visual field deficits. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | dB | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Pattern SD (PSD) is presented below. PSD provides information about localized loss. A higher PSD indicates a non-uniform sensitivity loss and visual field deficit. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | dB | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | Retinal Fundus Photography | As assessed by fundus photographs, participants were identified as either having retinopathy or not having retinopathy. Data is shown as number of people with retinopathy at a particular study visit. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Count of Participants | Participants | Baseline, 3 month, 12 months and 24 months |
|
|
|
|
| Secondary | Nerve Conduction Study (NCS) - Latency | Latency measures the time in millisecond between stimulation and the recording electrode. Was performed on sural, peroneal, and tibial nerves. No response and abnormal values indicate neuropathy.
| The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | ms | Baseline and 24 months |
|
|
|
|
| Secondary | Nerve Conduction Study (NCS) - Motor Amplitude | Amplitude measures the height of electrical signal (waveform) in millivolts produced by the stimulated motor nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy.
| The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | mV | Baseline and 24 months |
|
|
|
|
| Secondary | Nerve Conduction Study (NCS) - Sensory Amplitude | Amplitude measures the height of electrical signal (waveform) in microvolts produced by the stimulated sensory nerve. Was performed on sural nerve. No response and abnormal values indicate neuropathy. * Sural: 0 - No response, <4 - Abnormal | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | μV | Baseline and 24 months |
|
|
|
|
| Secondary | Nerve Conduction Study (NCS) - CV | Conduction velocity (V) measures the speed (m/s) at which the electrical impulse travels along the nerve. Was performed on peroneal nerves. No response and abnormal values indicate neuropathy. Abnormal values are <36 or 39, depending on whether certain criteria applied to the participant. Data was not analyzed separately. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | m/s | Baseline and 24 months |
|
|
|
|
| Secondary | Nerve Conduction Study (NCS) - F Wave Index | F wave index measures the time in millisecond between stimulation at a distal (near the muscle) point and for the stimulus to travel to the spinal cord and back, allowing to assess the entire length of the nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy.
| The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | ms | Baseline and 24 months |
|
|
|
|
| Secondary | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Deep breathing/exhalation to inhalation (E:I) ratio were evaluated using PS monitor software. Values < 1 are abnormal, indicative of cardiovascular autonomic neuropathy | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline and 24 months |
|
|
|
|
| Secondary | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Postural change-30:15 ratio was evaluated using PS monitor software. Values < 1 are abnormal, indicative of cardiovascular autonomic neuropathy | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline and 24 months |
|
|
|
|
| Secondary | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Valsalva ratio was evaluated using PS monitor software. Values <= 1.10 are abnormal, indicative of cardiovascular autonomic neuropathy | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline and 24 months |
|
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|
|
| Secondary | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | Toronto definition of probable neuropathy is having at least 2 out of 3 of the following: abnormal sensory examination, reflexes, and patient-reported symptoms. Data is reported as number of participants who, under the Toronto definition, were identified as having probable polyneuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Number | participants with probable neuropathy | 24 months |
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|
|
| Secondary | Michigan Neuropathy Screening Instrument (MNSI) | MNSI questionnaire is scored from 0-15, score > 4 indicate neuropathy, higher scores indicate worse neuropathy. A score of 1 point is given for answers of "yes" for questions 1-6, 8-12, 14, and 15 and "no" for questions 7 and 13. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month, 12 months and 24 months |
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|
|
| Secondary | Michigan Neuropathy Screening Instrument (MNSI) - Exam | MNSI exam is scored from 0-8, score >= 2.5 indicate neuropathy. Higher scores indicate worse neuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month, 12 months and 24 months |
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|
|
| Secondary | Michigan Neuropathy Screening Instrument (MNSI) - Index | The Michigan Neuropathy Screening Instrument (MNSI) index is a weighted composite score computed using the sum of the b-coefficients for all items within the MNSI questionnaire (15 questions) and MNSI exam (4 physical/visual exam). Range: -0.93, 7.39 Values > 2.5407 are indicative of clinical neuropathy | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | MNSI Score | Baseline, 3 month, 12 months and 24 months |
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|
|
| Secondary | Utah Early Neuropathy Score (UENS) | UENS is a composite score with five sections measuring multiple clinical measures of nerve injury. Sections are scored separately for each side (Right vs Left), and the total score is the sum across everything. Range: 0-42, higher score represents more severe polyneuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month, 12 months and 24 months |
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|
|
| Secondary | Modified Toronto Neuropathy Score (mTNS) | mTNS is a scale of 0-33 that measures neuropathy symptoms and exam findings. Higher scores indicate more severe polyneuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month, 12 months and 24 months |
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|
|
| Secondary | Survey of Autonomic Symptoms (SAS) | SAS evaluates the presence and magnitude of autonomic symptoms. Total impact score ranges from 0-60 (or up to 55 for participants to whom certain criteria did not apply). Higher score indicates worse autonomic neuropathy | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month, 12 months and 24 months |
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|
|
| Secondary | Diabetic Neuropathy Score (DNS) | DNS is a questionnaire of neuropathy symptoms. Score ranges 0-4, >/=1 indicates polyneuropathy. 0 indicates no polyneuropathy. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month, 12 months and 24 months |
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|
| Secondary | Short Form McGill Pain Questionnaire | Sum of the sensory score (0-30) and affective score (0-15) for a total score of 0-45. A higher score represents greater pain present. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 12 months, 24 months |
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|
|
| Secondary | Numerical Rating Scale for Pain | Participant reported pain scale with range 0-10, higher score indicates more pain. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 12 months, 24 months |
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|
|
| Secondary | Neuropathy Quality of Life (NeuroQOL) | Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | NeuroQOL Score | Baseline, 3 months, 12 months, and 24 months |
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| Secondary | 8 Foot Get Up and Go Test | This test measures in seconds how long it takes the participant to stand up from a seated position, walk around a cone places 8 feet away, and return to the chair and sit down. Less time indicates better speed, agility, and balance when moving. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | Seconds | Baseline, 3 months, 12 months, and 24 months |
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| Secondary | Berg Balance Scale | Berg Balance Scale measures participants' ability to balance and avoid falls. Scores range from 0-56, higher score indicates less likely to fall. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 12 months, and 24 months |
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|
| Secondary | Modified Falls Efficacy Scale - Fall Evaluation | Patient response indicating if they have fallen in the last year. Data is shown as number of people who have fallen in the last year. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Count of Participants | Participants | Baseline, 3 months, 12 months, and 24 months |
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| Secondary | Neurothesiometer | Neurothesiometer is placed on the bottom of the great toe, and slowly increased until participant reports they can feel the vibration. The greater the microns, the less feeling the participant has, suggestive of worse sensory function. Value > 25 Microns is indicative of neuropathy. There is no known maximum range. Lower values indicate better sensory function. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | Microns | Baseline, 3 months, 12 months, and 24 months |
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|
| Secondary | NIH Toolbox Cognitive Battery | NIH Toolbox Cognition Fluid (Range: 0-100) - Composite score derived as an average across five cognitive domains. It's a fully adjusted T-score comparing the participant to a nationally representative sample, stratified by age and other demographics. Individual domain scores are fully adjusted T score with range 0-100 and measures the following-
A T-score of 50 represents the population mean. A score of 60 indicates that the participant is 1 SD above the national average for individuals with similar demographic characteristics Higher scores reflect better cognitive functionality. No set clinical threshold, scores above mean indicate above average cognition for a given age group. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | T-score | Baseline and at 24 months |
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| Secondary | Rey Auditory Verbal Learning Test | Used to evaluate verbal learning and memory using a list of 15 unrelated words presented to the participant over repeat trial. Includes 3 independent scales:
No set clinical threshold, scores above mean indicate above average cognition for a given age group. | The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline and at 24 months |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | No Bariatric Surgery/HIIT | High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months. Procedure/Surgery: None | 0 | 35 | 0 | 35 | 2 | 35 |
| EG002 | Bariatric Surgery/Routine Exercise | Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care. | 0 | 35 | 0 | 35 | 1 | 35 |
| EG003 | No Bariatric Surgery/Routine Exercise | Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation). Procedure/Surgery: None | 0 | 35 | 0 | 35 | 0 | 35 |
| Injury During Exercise | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 0.18 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -1.09 |
| 2-Sided |
| 95 |
| -2.71 |
| 0.53 |
| Superiority |
| t-test, 2 sided | 0.21 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 1.32 | 2-Sided | 95 | -0.82 | 3.48 | Superiority |
| Mixed Models Analysis | 0.66 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.02 | 2-Sided | 95 | -0.05 | 0.09 | Superiority |
| Mixed Models Analysis | 0.25 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.05 | 2-Sided | 95 | -0.02 | 0.11 | Superiority |
| Mixed Models Analysis | 0.09 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | -0.06 | 2-Sided | 95 | -0.13 | 0.01 | Superiority |
|
| 3 Months-Corneal Nerve Fiber Density (fibers/mm2) |
|
|
| 12 Months-Corneal Nerve Fiber Density (fibers/mm2) |
|
|
| 24 Months-Corneal Nerve Fiber Density (fibers/mm2) |
|
|
| 0.03 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -3.82 |
| 2-Sided |
| 95 |
| -7.32 |
| -0.31 |
| Superiority |
| t-test, 2 sided | 0.38 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -1.56 | 2-Sided | 95 | -5.18 | 2.05 | Superiority |
|
| 3 Months-Corneal Nerve Branch Density (branches/mm2) |
|
|
| 12 Months-Corneal Nerve Branch Density (branches/mm2) |
|
|
| 24 Months-Corneal Nerve Branch Density (branches/mm2) |
|
|
| 0.95 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| t-test, 2 sided | 0.59 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 3 Months-Corneal Nerve Fiber Length (mm/mm2) |
|
|
| 12 Months-Corneal Nerve Fiber Length (mm/mm2) |
|
|
| 24 Months-Corneal Nerve Fiber Length (mm/mm2) |
|
|
| 0.83 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.43 |
| 2-Sided |
| 95 |
| -4.64 |
| 3.76 |
| Superiority |
| t-test, 2 sided | 0.82 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.51 | 2-Sided | 95 | -4.27 | 5.3 | Superiority |
| Mixed Models Analysis | 0.51 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.05 | 2-Sided | 95 | -0.11 | 0.21 | Superiority |
| Mixed Models Analysis | 0.60 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.04 | 2-Sided | 95 | -0.11 | 0.19 | Superiority |
| Mixed Models Analysis | 0.99 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Mean Difference (Net) | 0.002 | 2-Sided | 95 | -0.17 | 0.17 | Superiority |
|
| 3 Months-Corneal Tortuosity (coefficient value) |
|
|
| 12 Months-Corneal Tortuosity (coefficient value) |
|
|
| 24 Months-Corneal Tortuosity (coefficient value) |
|
|
| 0.21 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| t-test, 2 sided | 0.33 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 3 Months-Mean Deviation |
|
|
| 12 Months-Mean Deviation |
|
|
| 24 Months-Mean Deviation |
|
|
| 0.71 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.35 |
| 2-Sided |
| 95 |
| -2.26 |
| 1.56 |
| Superiority |
| t-test, 2 sided | 0.92 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.10 | 2-Sided | 95 | -2.10 | 2.31 | Superiority |
| Mixed Models Analysis | 0.98 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference of slope | 0.001 | 2-Sided | 95 | -0.08 | 0.08 | Superiority |
| Mixed Models Analysis | 0.66 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.02 | 2-Sided | 95 | -0.06 | 0.10 | Superiority |
| Mixed Models Analysis | 0.66 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | -0.02 | 2-Sided | 95 | -0.10 | 0.06 | Superiority |
|
| 3 Months--Foveal Sensitivity |
|
|
| 12 Months--Foveal Sensitivity |
|
|
| 24 Months--Foveal Sensitivity |
|
|
| 0.58 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| t-test, 2 sided | 0.97 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 3 Months-Patter SD |
|
|
| 12 Months-Patter SD |
|
|
| 24 Months-Patter SD |
|
|
| 0.98 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| t-test, 2 sided | 0.88 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 1 |
The P-value tests whether the change in participant count (as either having retinopathy or not having retinopathy) from baseline to 2 years differs between the treatment and no-treatment groups. |
| 2-Sided |
| Superiority |
| Fisher Exact | 0.44 | The P-value tests whether the change in participant count (as either having retinopathy or not having retinopathy) from baseline to 2 years differs between the treatment and no-treatment groups. | 2-Sided | Superiority |
|
| Baseline-Sural peak latency (ms) |
|
|
| Baseline-Tibial distal motor latency (ms) |
|
|
| 24 Months-Peroneal distal motor latency (ms) |
|
|
| 24 Months-Sural peak latency (ms) |
|
|
| 24 Months-Tibial distal motor latency (ms) |
|
|
Measure -Peroneal distal motor latency (ms) |
| t-test, 2 sided |
| 0.33 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.20 |
| 2-Sided |
| 95 |
| -0.62 |
| 0.21 |
| Superiority |
| Measure -Peroneal distal motor latency (ms) | t-test, 2 sided | 0.75 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.06 | 2-Sided | 95 | -0.36 | 0.49 | Superiority |
| Measure - Sural peak latency (ms) | t-test, 2 sided | 0.45 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.13 | 2-Sided | 95 | -0.49 | 0.23 | Superiority |
| Measure -Sural peak latency (ms) | t-test, 2 sided | 0.13 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.24 | 2-Sided | 95 | -0.57 | 0.08 | Superiority |
| Measure -Sural peak latency (ms) | t-test, 2 sided | 0.03 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.41 | 2-Sided | 95 | -0.79 | -0.03 | Superiority |
| Measure - Tibial distal motor latency (ms) | t-test, 2 sided | 0.05 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.50 | 2-Sided | 95 | -0.002 | 1.01 | Superiority |
| Measure - Tibial distal motor latency (ms) | t-test, 2 sided | 0.08 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.48 | 2-Sided | 95 | -0.07 | 1.03 | Superiority |
| Measure - Tibial distal motor latency (ms) | t-test, 2 sided | 0.38 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.21 | 2-Sided | 95 | -0.27 | 0.70 | Superiority |
|
| Baseline-Tibial amplitude (mV) |
|
|
| 24 Months-Peroneal amplitude (mV) |
|
|
| 24 Months-Tibial amplitude (mV) |
|
|
Measure - Peroneal amplitude (mV)
| t-test, 2 sided |
| 0.31 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| Measure - Peroneal amplitude (mV) | t-test, 2 sided | 0.23 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Measure - Tibial amplitude (mV) | t-test, 2 sided | 0.65 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Measure - Tibial amplitude (mV) | t-test, 2 sided | 0.69 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Measure - Tibial amplitude (mV) | t-test, 2 sided | 0.69 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 24 Months-Sural amplitude (µV) |
|
|
Measure - Sural amplitude (µV)
| t-test, 2 sided |
| 0.26 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| Measure - Sural amplitude (µV) | t-test, 2 sided | 0.62 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 24 Months-Peroneal CV (m/s) |
|
|
Measure - Peroneal CV (m/s)
| t-test, 2 sided |
| 0.27 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| Measure - Peroneal CV (m/s) | t-test, 2 sided | 0.52 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| Baseline-Tibial F wave index (ms) |
|
|
| 24 Months-Peroneal F wave index (ms) |
|
|
| 24 Months-Tibial F wave index (ms) |
|
|
Measure - Peroneal F wave index (ms)
| t-test, 2 sided |
| 0.43 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| Measure - Peroneal F wave index (ms) | t-test, 2 sided | 0.48 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Measure - Tibial F wave index (ms) | t-test, 2 sided | 0.75 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Measure - Tibial F wave index (ms) | t-test, 2 sided | 0.09 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Measure - Tibial F wave index (ms) | t-test, 2 sided | 0.03 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 24 Months |
|
|
| 0.46 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.05 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.01 |
| Superiority |
| t-test, 2 sided | 0.24 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.01 | 2-Sided | 95 | -0.26 | 0.07 | Superiority |
| Mixed Models Analysis | 0.98 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.001 | 2-Sided | 95 | -0.01 | 0.01 | Superiority |
| Mixed Models Analysis | 0.49 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.002 | 2-Sided | 95 | -0.004 | 0.01 | Superiority |
| Mixed Models Analysis | 0.17 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.004 | 2-Sided | 95 | -0.002 | 0.01 | Superiority |
|
| 24 Months |
|
|
| 0.72 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| 0.024 |
| 2-Sided |
| 95 |
| -0.11 |
| 0.16 |
| Superiority |
| t-test, 2 sided | 0.33 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.06 | 2-Sided | 95 | -0.06 | 0.19 | Superiority |
|
| 24 Months |
|
|
| 0.15 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| 0.13 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.31 |
| Superiority |
| t-test, 2 sided | 0.20 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.11 | 2-Sided | 95 | -0.06 | 0.30 | Superiority |
|
| 24 Months |
|
|
| Wilcoxon (Mann-Whitney) |
| 0.34 |
| Wilcoxon test statistic |
| 3 |
| 2-Sided |
| Superiority |
| Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment group | Wilcoxon (Mann-Whitney) | 0.42 | Wilcoxon test statistic | 2.5 | 2-Sided | Superiority |
| Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment group | Wilcoxon (Mann-Whitney) | 0.77 | Wilcoxon test statistic | 9 | 2-Sided | Superiority |
|
| 3 Months Questionnaire |
|
|
| 12 Months Questionnaire |
|
|
| 24 Months Questionnaire |
|
|
Questionnaire |
| t-test, 2 sided |
| 0.85 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.09 |
| 2-Sided |
| 95 |
| -0.98 |
| 0.80 |
| Superiority |
| Questionnaire | t-test, 2 sided | 0.37 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.46 | 2-Sided | 95 | -0.58 | 1.50 | Superiority |
| Questionnaire | Mixed Models Analysis | 0.78 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 1.00 | 2-Sided | 95 | 0.99 | 1.02 | Superiority |
| Questionnaire | Mixed Models Analysis | 0.53 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.99 | 2-Sided | 95 | 0.98 | 1.01 | Superiority |
| Questionnaire | Mixed Models Analysis | 0.08 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.98 | 2-Sided | 95 | 0.96 | 1.00 | Superiority |
|
| 3 Months Exam |
|
|
| 12 Months Exam |
|
|
| 24 Months Exam |
|
|
| 0.04 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| t-test, 2 sided | 0.47 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
| Mixed Models Analysis | 0.18 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.98 | 2-Sided | 95 | 0.96 | 1.01 | Superiority |
| Mixed Models Analysis | 0.52 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.99 | 2-Sided | 95 | 0.96 | 1.02 | Superiority |
| Mixed Models Analysis | 0.87 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 1.00 | 2-Sided | 95 | 0.97 | 1.02 | Superiority |
|
| 3 Months Index |
|
|
| 12 Months Index |
|
|
| 24 Months Index |
|
|
| 0.57 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Superiority |
| t-test, 2 sided | 0.61 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Superiority |
|
| 3 Months UENS Total Score |
|
|
| 12 Months UENS Total Score |
|
|
| 24 Months UENS Total Score |
|
|
Total Score |
| t-test, 2 sided |
| 0.97 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.03 |
| 2-Sided |
| 95 |
| -2.16 |
| 2.10 |
| Superiority |
| Total Score | t-test, 2 sided | 0.71 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.40 | 2-Sided | 95 | -1.78 | 2.58 | Superiority |
| Total Score | Mixed Models Analysis | 0.99 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 1.00 | 2-Sided | 95 | 0.98 | 1.02 | Superiority |
| Total Score | Mixed Models Analysis | 0.88 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 1.00 | 2-Sided | 95 | 0.98 | 1.02 | Superiority |
| Total Score | Mixed Models Analysis | 0.09 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.99 | 2-Sided | 95 | 0.97 | 1.00 | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 0.63 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.59 |
| 2-Sided |
| 95 |
| -3.14 |
| 1.95 |
| Superiority |
| t-test, 2 sided | 0.43 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 1.01 | 2-Sided | 95 | -1.55 | 3.58 | Superiority |
| Mixed Models Analysis | 0.43 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.99 | 2-Sided | 95 | 0.98 | 1.01 | Superiority |
| Mixed Models Analysis | 0.83 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 1.00 | 2-Sided | 95 | 0.98 | 1.02 | Superiority |
| Mixed Models Analysis | <0.01 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.97 | 2-Sided | 95 | 0.94 | 0.99 | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 0.48 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| 2.70 |
| 2-Sided |
| 95 |
| -7.57 |
| 12.97 |
| Superiority |
| t-test, 2 sided | 0.64 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.87 | 2-Sided | 95 | -4.94 | 3.18 | Superiority |
|
| 3 Months |
|
|
| 12 Moths |
|
|
| 24 Months |
|
|
| 0.24 |
The P-value tests whether the within-participant change in the group from baseline to 2 years is significant |
| Median Difference (Net) |
| -0.3 |
| Standard Deviation |
| 0.9 |
| 2-Sided |
| Superiority |
| t-test, 2 sided | 0.45 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Mean Difference (Net) | -0.2 | Standard Deviation | 1.1 | 2-Sided | Superiority |
| t-test, 2 sided | 0.84 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Mean Difference (Net) | -0.1 | Standard Deviation | 1.5 | 2-Sided | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
Mcgill Total Score
| t-test, 2 sided |
| 0.56 |
The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group |
| Mean Difference (Net) |
| -0.97 |
| 2-Sided |
| 95 |
| -4.36 |
| 2.41 |
| Superiority |
| Mcgill Total Score | t-test, 2 sided | 0.21 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Mean Difference (Net) | -1.72 | 2-Sided | 95 | -4.5 | 1.05 | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 0.92 |
The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group |
| Superiority |
| t-test, 2 sided | 0.90 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Superiority |
| Mixed Models Analysis | 0.46 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | -0.02 | 2-Sided | 95 | -0.06 | 0.03 | Superiority |
| Mixed Models Analysis | 0.47 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | -0.02 | 2-Sided | 95 | -0.06 | 0.03 | Superiority |
| Mixed Models Analysis | 0.91 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | 0.003 | 2-Sided | 95 | -0.04 | 0.05 | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
NeuroQOL- overall QOL |
| t-test, 2 sided |
| 0.97 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| 0.01 |
| 2-Sided |
| 95 |
| -0.76 |
| 0.78 |
| Superiority |
| NeuroQOL- overall QOL | t-test, 2 sided | 0.76 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.09 | 2-Sided | 95 | -0.73 | 0.54 | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 0.80 |
The P-value tests whether the within-participant change in the group from baseline to 2 years is significant |
| Mean Difference (Net) |
| -0.1 |
| Standard Deviation |
| 1 |
| 2-Sided |
| Superiority |
| t-test, 2 sided | 0.86 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Mean Difference (Net) | 0.1 | Standard Deviation | 1.4 | 2-Sided | Superiority |
| t-test, 2 sided | 0.46 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Mean Difference (Net) | 0.3 | Standard Deviation | 1.4 | 2-Sided | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 0.72 |
The P-value tests whether the within-participant change in the group from baseline to 2 years is significant |
| Mean Difference (Net) |
| 0.11 |
| Standard Deviation |
| 1.15 |
| 2-Sided |
| Superiority |
| t-test, 2 sided | 0.55 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Mean Difference (Net) | -0.31 | Standard Deviation | 2.07 | 2-Sided | Superiority |
| t-test, 2 sided | 0.28 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Mean Difference (Net) | 0.57 | Standard Deviation | 2.7 | 2-Sided | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
The P-value tests whether the within-participant change in the group from baseline to 2 years is significant |
| Superiority |
| t-test, 2 sided | 0.77 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Superiority |
| t-test, 2 sided | 0.24 | The P-value tests whether the within-participant change in the group from baseline to 2 years is significant | Superiority |
|
| 3 Months |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| <0.01 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| 4.5 |
| 2-Sided |
| 95 |
| 1.31 |
| 7.71 |
| Superiority |
| t-test, 2 sided | 0.30 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 5.62 | 2-Sided | 95 | -5.37 | 16.63 | Superiority |
|
| Baseline Dimensional Change Card Sort Test |
|
|
| Baseline Picture Sequence Memory Test |
|
|
| Baseline List Sorting Working Memory Test |
|
|
| Baseline Pattern Comparison Processing Speed Test |
|
|
| Baseline Cognition Fluid Composite |
|
|
| 24 Months Inhibitory Control and Attention Test |
|
|
| 24 Months Dimensional Change Card Sort Test |
|
|
| 24 Months Picture Sequence Memory Test |
|
|
| 24 Months List Sorting Working Memory Test |
|
|
| 24 Months Pattern Comparison Processing Speed Test |
|
|
| 24 Months Cognition Fluid Composite |
|
|
Inhibitory Control and Attention Test |
| t-test, 2 sided |
| 0.33 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| 1.91 |
| 2-Sided |
| 95 |
| -2.05 |
| 5.88 |
| Superiority |
| Inhibitory Control and Attention Test | t-test, 2 sided | 0.49 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 1.43 | 2-Sided | 95 | -2.72 | 5.59 | Superiority |
| Dimensional Change Card Sort Test | t-test, 2 sided | 0.35 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 2.97 | 2-Sided | 95 | -3.48 | 9.44 | Superiority |
| Dimensional Change Card Sort Test | t-test, 2 sided | 0.10 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 5.6 | 2-Sided | 95 | -3.48 | 9.44 | Superiority |
| Dimensional Change Card Sort Test | t-test, 2 sided | 0.32 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 3.24 | 2-Sided | 95 | -3.34 | 9.82 | Superiority |
| Picture Sequence Memory Test | t-test, 2 sided | 0.49 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 2.4 | 2-Sided | 95 | -4.57 | 9.37 | Superiority |
| Picture Sequence Memory Test | t-test, 2 sided | 0.30 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 3.2 | 2-Sided | 95 | -3.03 | 9.56 | Superiority |
| Picture Sequence Memory Test | t-test, 2 sided | 0.86 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Median Difference (Net) | 0.49 | 2-Sided | 95 | -5.40 | 6.38 | Superiority |
| List Sorting Working Memory Test | t-test, 2 sided | 0.88 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.42 | 2-Sided | 95 | -5.39 | 6.24 | Superiority |
| List Sorting Working Memory Test | t-test, 2 sided | 0.83 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.60 | 2-Sided | 95 | -5.14 | 6.31 | Superiority |
| List Sorting Working Memory Test | t-test, 2 sided | 0.81 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.62 | 2-Sided | 95 | -6.02 | 4.76 | Superiority |
| Pattern Comparison Processing Speed Test | t-test, 2 sided | 0.12 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -5.29 | 2-Sided | 95 | -12.1 | 1.57 | Superiority |
| Pattern Comparison Processing Speed Test | t-test, 2 sided | 0.63 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -1.84 | 2-Sided | 95 | -9.53 | 5.84 | Superiority |
| Pattern Comparison Processing Speed Test | t-test, 2 sided | 0.40 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -2.87 | 2-Sided | 95 | -9.80 | 4.05 | Superiority |
| Cognition Fluid Composite | t-test, 2 sided | 0.65 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 1.04 | 2-Sided | 95 | -3.63 | 5.73 | Superiority |
| Cognition Fluid Composite | t-test, 2 sided | 0.27 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 2.68 | 2-Sided | 95 | -2.17 | 7.54 | Superiority |
| Cognition Fluid Composite | t-test, 2 sided | 0.90 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.27 | 2-Sided | 95 | -4.10 | 4.65 | Superiority |
| Cognition Fluid Composite | Mixed Models Analysis | 0.85 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | -0.02 | 2-Sided | 95 | -0.21 | 0.17 | Superiority |
| Cognition Fluid Composite | Mixed Models Analysis | 0.28 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Interaction term for difference in slope | -0.10 | 2-Sided | 95 | -0.29 | 0.09 | Superiority |
| Cognition Fluid Composite | Mixed Models Analysis | 0.99 | The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group | Mean Difference (Net) | 0.001 | 2-Sided | 95 | -0.18 | 0.19 | Superiority |
|
| Baseline Delayed Recall |
|
|
| Baseline Recognition |
|
|
| 24 Months Auditory Learning |
|
|
| 24 Months Delayed Recall |
|
|
| 24 Months Recognition |
|
|
Auditory Learning |
| t-test, 2 sided |
| 0.33 |
The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. |
| Mean Difference (Net) |
| -0.26 |
| 2-Sided |
| 95 |
| -0.81 |
| 0.28 |
| Superiority |
| Auditory Learning | t-test, 2 sided | 0.22 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Median Difference (Net) | -0.38 | 2-Sided | 95 | -1.00 | 0.23 | Superiority |
| Delayed Recall | t-test, 2 sided | 0.27 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.29 | 2-Sided | 95 | -0.23 | 0.81 | Superiority |
| Delayed Recall | t-test, 2 sided | 0.54 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.16 | 2-Sided | 95 | -0.69 | 0.37 | Superiority |
| Delayed Recall | t-test, 2 sided | 0.93 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.02 | 2-Sided | 95 | -0.57 | 0.53 | Superiority |
| Recognition | t-test, 2 sided | 0.64 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.14 | 2-Sided | 95 | -0.46 | 0.74 | Superiority |
| Recognition | t-test, 2 sided | 0.37 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | -0.21 | 2-Sided | 95 | -0.70 | 0.27 | Superiority |
| Recognition | t-test, 2 sided | 0.88 | The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups. | Mean Difference (Net) | 0.04 | 2-Sided | 95 | -0.59 | 0.69 | Superiority |