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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK099334-01A1 | U.S. NIH Grant/Contract | View source | |
| OCR15981 | Other Identifier | Universiy of Florida |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.
There will be two groups of people studied:
One group has chosen (independently of this research study) to have weight loss surgery to help them lose weight.
Another group will not choose to have any weight loss surgery. All research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will have an MRI Brain Scan at those same times also to look at changes in the structure and function of the brain tissue.
Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery Candidates | Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH & Shands Hospital. |
| |
| Non surgical/Community volunteers | Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric Surgery Candidates | Procedure | Participants who are intending to have bariatric surgery for weight loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BOLD fMRI Signal | Brain activation changes will change in the frontal cortex and hippocampus.
| Change from baseline at 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Potential bariatric surgery patients will have study specific information made available to them for their consideration at the bariatric or diabetes clinics at UFHealth & Shands Hospital, or at other community locations. Flyers will be posted in many community advertising locations in the North Florida region. Prospective participants must live in Gainesville, FL or the surrounding areas to be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Ronald A Cohen, PHD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida - College of Public Health and Health Professions | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31116012 | Derived | Fernando HJ, Cohen RA, Gullett JM, Friedman J, Ayzengart A, Porges E, Woods AJ, Gunstad J, Ochoa CM, Cusi K, Gonzalez-Louis R, Donahoo WT. Neurocognitive Deficits in a Cohort With Class 2 and Class 3 Obesity: Contributions of Type 2 Diabetes and Other Comorbidities. Obesity (Silver Spring). 2019 Jul;27(7):1099-1106. doi: 10.1002/oby.22508. Epub 2019 May 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bariatric Surgery Candidates | Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH & Shands Hospital. Bariatric Surgery Candidates: Participants who are intending to have bariatric surgery for weight loss |
| FG001 | Non Surgical/Community Volunteers | Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss Non surgical/Community volunteers: Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bariatric Surgery Candidates | Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH & Shands Hospital. Bariatric Surgery Candidates: Participants who are intending to have bariatric surgery for weight loss |
| BG001 | Non Surgical/Community Volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in BOLD fMRI Signal | Brain activation changes will change in the frontal cortex and hippocampus.
| 37 individuals completed pre-surgery MRI at baseline and 18-month follow-up. | Posted | Mean | Standard Deviation | Connectivity Fisher-z transformation | Change from baseline at 18 months |
|
18 months
Consistent with clinicaltrials.gov
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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 | Surgical Group | Participants that received surgery | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-surgical Symptoms | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MRI symptoms | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald Cohen | University of Florida | 352-273-6124 | roncohen@ufl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol Document | Jan 20, 2022 | Jul 17, 2024 | Prot_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: ICF Document | Jan 3, 2019 | Jul 17, 2024 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Blood samples will be retained for biomarker analysis.
| Non surgical/Community volunteers | Other | Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss Non surgical/Community volunteers: Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Mean | Standard Deviation | 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 |
|
| Age of study participants | Mean | Standard Deviation | years |
|
| OG001 | Non Surgical/Community Volunteers | Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss Non surgical/Community volunteers: Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss |
|
|
|
| 150 |
| 5 |
| 150 |
| 11 |
| 150 |
| EG001 | Control Group | Participants that did not receive surgery | 0 | 47 | 0 | 47 | 3 | 47 |
| High BDI | Psychiatric disorders | Non-systematic Assessment |
|
| Blood draw problems | General disorders | Non-systematic Assessment |
|
| Other tasks | General disorders | Non-systematic Assessment |
|
| Survey Questions/Cognitive questions | Social circumstances | Non-systematic Assessment |
|
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| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |