Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
This project proposes a longitudinal design that uses multinuclear-MRI to evaluate the mechanistic effects of exercise on skeletal muscle function and peripheral nerve integrity in patients with diabetic peripheral neuropathy (DPN), and to determine whether exercise can reverse DPN symptoms. The investigators will prescribe a 10-week exercise program to 40 DPN patients. The investigators will acquire multinuclear-MRI data before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function and peripheral nerve integrity of patients with DPN, and their role in improving DPN symptoms following physical exercise intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Type 2 Diabetes and Clinical Symptoms of DPN | Experimental | Patients will be individually prescribed to a 10-week exercise program with both aerobic and resistance components. Prior to beginning the intervention, patients will participate in a maximal graded exercise test (VO2R) using a cycle ergometer with a metabolic cart and integrated ECG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Procedure | The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | The BMI calculation divides an adult's weight in kilograms by their height in meters squared. | Baseline |
| Change From Baseline in Body Mass Index (BMI) | The BMI calculation divides an adult's weight in kilograms by their height in meters squared. | Week 10 |
| Glycosylated Hemoglobin (HbA1c) | The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. Measured via patient blood samples. | Baseline |
| Glycosylated Hemoglobin (HbA1c) | The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. Measured via patient blood samples. | Week 10 |
| C-Reactive Protein Levels | Measured via patient blood samples. | Baseline |
| C-Reactive Protein Levels | Measured via patient blood samples. | Week 10 |
| Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire | 15-question assessment of symptoms. Responses of "yes" to items 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Item 4 is a measure of impaired circulation and item 10 is a measure of general asthenia; neither are included in scoring. The total score ranges from 0-13; lower scores indicate less prevalent symptoms; a decrease in scores indicates symptoms decreased during the observational period. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Brown, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Type 2 Diabetes and Clinical Symptoms of DPN | Patients will be individually prescribed to a 10-week exercise program with both aerobic and resistance components. Prior to beginning the intervention, patients will participate in a maximal graded exercise test (VO2R) using a cycle ergometer with a metabolic cart and integrated ECG. Exercise Program: The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Type 2 Diabetes and Clinical Symptoms of DPN | Patients will be individually prescribed to a 10-week exercise program with both aerobic and resistance components. Prior to beginning the intervention, patients will participate in a maximal graded exercise test (VO2R) using a cycle ergometer with a metabolic cart and integrated ECG. Exercise Program: The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Body Mass Index (BMI) | The BMI calculation divides an adult's weight in kilograms by their height in meters squared. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline |
|
10 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Type 2 Diabetes and Clinical Symptoms of DPN | Patients will be individually prescribed to a 10-week exercise program with both aerobic and resistance components. Prior to beginning the intervention, patients will participate in a maximal graded exercise test (VO2R) using a cycle ergometer with a metabolic cart and integrated ECG. Exercise Program: The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Brown, PhD | NYU Langone Health | 2122633396 | Ryan.Brown@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2022 | Apr 3, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline |
| Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire | 15-question assessment of symptoms. Responses of "yes" to items 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Item 4 is a measure of impaired circulation and item 10 is a measure of general asthenia; neither are included in scoring. The total score ranges from 0-13; lower scores indicate less prevalent symptoms; a decrease in scores indicates symptoms decreased during the observational period. | Week 10 |
| MNSI Physical Exam Score | Completed by physician. Assessment of abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation. The total score ranges from 0-10; lower scores indicate greater physical health; a decrease in scores indicates physical health increased during the observational period. | Baseline |
| MNSI Physical Exam Score | Completed by physician. Assessment of abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation. The total score ranges from 0-10; lower scores indicate greater physical health; a decrease in scores indicates physical health increased during the observational period. | Week 10 |
| Calf Muscle Performance | Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec. | Baseline |
| Calf Muscle Performance | Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec. | Week 10 |
| Physical Performance Test (PP) Score | 9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance. | Baseline |
| Physical Performance Test (PP) Score | 9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance. | Week 10 |
| PCr Resynthesis Rate in the Gastrocnemius Muscle Groups | Measured using multinuclear-MRI following a 90-second plantar flexion exercise during which resistance is applied at approximately 40% of the individual's maximum voluntary contraction. The value reported in the data table represents the average flexion across both calf muscles. | Baseline |
| PCr Resynthesis Rate in the Gastrocnemius Muscle Groups | Measured using multinuclear-MRI following a 90-second plantar flexion exercise during which resistance is applied at approximately 40% of the individual's maximum voluntary contraction. The value reported in the data table represents the average flexion across both calf muscles. | Week 10 |
| Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined. | Baseline |
| Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined. | Week 10 |
| IMAT Levels in the Soleus Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined. | Baseline |
| IMAT Levels in the Soleus Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined. | Week 10 |
| Fractional Anisotropy (FA) in the Tibial Nerve | FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Measured using Diffusion Tensor Imaging (DTI). | Baseline |
| Fractional Anisotropy (FA) in the Tibial Nerve | FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Measured using Diffusion Tensor Imaging (DTI). | Week 10 |
| Apparent Diffusion Coefficient (ADC) in the Tibial Nerve | ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI. | Baseline |
| Apparent Diffusion Coefficient (ADC) in the Tibial Nerve | ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI. | Week 10 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change From Baseline in Body Mass Index (BMI) | The BMI calculation divides an adult's weight in kilograms by their height in meters squared. | Posted | Mean | Standard Deviation | kg/m^2 | Week 10 |
|
|
|
| Primary | Glycosylated Hemoglobin (HbA1c) | The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. Measured via patient blood samples. | Posted | Mean | Standard Deviation | percentage (%) of HbA1c | Baseline |
|
|
|
| Primary | Glycosylated Hemoglobin (HbA1c) | The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. Measured via patient blood samples. | Posted | Mean | Standard Deviation | percentage (%) of HbA1c | Week 10 |
|
|
|
| Primary | C-Reactive Protein Levels | Measured via patient blood samples. | Posted | Mean | Standard Deviation | mg/L | Baseline |
|
|
|
| Primary | C-Reactive Protein Levels | Measured via patient blood samples. | Posted | Mean | Standard Deviation | mg/L | Week 10 |
|
|
|
| Primary | Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire | 15-question assessment of symptoms. Responses of "yes" to items 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Item 4 is a measure of impaired circulation and item 10 is a measure of general asthenia; neither are included in scoring. The total score ranges from 0-13; lower scores indicate less prevalent symptoms; a decrease in scores indicates symptoms decreased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire | 15-question assessment of symptoms. Responses of "yes" to items 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Item 4 is a measure of impaired circulation and item 10 is a measure of general asthenia; neither are included in scoring. The total score ranges from 0-13; lower scores indicate less prevalent symptoms; a decrease in scores indicates symptoms decreased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Week 10 |
|
|
|
| Primary | MNSI Physical Exam Score | Completed by physician. Assessment of abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation. The total score ranges from 0-10; lower scores indicate greater physical health; a decrease in scores indicates physical health increased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | MNSI Physical Exam Score | Completed by physician. Assessment of abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation. The total score ranges from 0-10; lower scores indicate greater physical health; a decrease in scores indicates physical health increased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Week 10 |
|
|
|
| Primary | Calf Muscle Performance | Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec. | Posted | Mean | Standard Deviation | newton-meters | Baseline |
|
|
|
| Primary | Calf Muscle Performance | Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec. | Posted | Mean | Standard Deviation | newton-meters | Week 10 |
|
|
|
| Primary | Physical Performance Test (PP) Score | 9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Physical Performance Test (PP) Score | 9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance. | Posted | Mean | Standard Deviation | score on a scale | Week 10 |
|
|
|
| Primary | PCr Resynthesis Rate in the Gastrocnemius Muscle Groups | Measured using multinuclear-MRI following a 90-second plantar flexion exercise during which resistance is applied at approximately 40% of the individual's maximum voluntary contraction. The value reported in the data table represents the average flexion across both calf muscles. | Posted | Mean | Standard Deviation | mM/seconds | Baseline |
|
|
|
| Primary | PCr Resynthesis Rate in the Gastrocnemius Muscle Groups | Measured using multinuclear-MRI following a 90-second plantar flexion exercise during which resistance is applied at approximately 40% of the individual's maximum voluntary contraction. The value reported in the data table represents the average flexion across both calf muscles. | Posted | Mean | Standard Deviation | mM/seconds | Week 10 |
|
|
|
| Primary | Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined. | Posted | Mean | Standard Deviation | percentage of tissue | Baseline |
|
|
|
| Primary | Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined. | Posted | Mean | Standard Deviation | percentage of tissue | Week 10 |
|
|
|
| Primary | IMAT Levels in the Soleus Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined. | Posted | Mean | Standard Deviation | percentage of tissue | Baseline |
|
|
|
| Primary | IMAT Levels in the Soleus Muscle Groups | Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined. | Posted | Mean | Standard Deviation | percentage of tissue | Week 10 |
|
|
|
| Primary | Fractional Anisotropy (FA) in the Tibial Nerve | FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Measured using Diffusion Tensor Imaging (DTI). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Fractional Anisotropy (FA) in the Tibial Nerve | FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Measured using Diffusion Tensor Imaging (DTI). | Posted | Mean | Standard Deviation | score on a scale | Week 10 |
|
|
|
| Primary | Apparent Diffusion Coefficient (ADC) in the Tibial Nerve | ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI. | Posted | Mean | Standard Deviation | x10^3 mm^2/s | Baseline |
|
|
|
| Primary | Apparent Diffusion Coefficient (ADC) in the Tibial Nerve | ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI. | Posted | Mean | Standard Deviation | x10^3 mm^2/s | Week 10 |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 5 |
| 44 |
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ventricular ectopy | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |