The WISE (Weightloss Intervention Surgical Effects) Brain Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function

Conditions
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Diabetes, Weightloss

Intervention / Treatment
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* Procedure: Bariatric Surgery Candidates
* Other: Non surgical/Community volunteers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index >35 Diabetes or no diabetes Compatible with MRI Scanning Willing to give a small blood sample on 3 occasions Capable of providing informed consent Exclusion Criteria: Prior neurological disorder Mini Mental Status Exam score Major psychiatric disturbance (schizophrenia, chronic intractable depression, Coronary revascularization, peripheral vascular disease Severe cardio vascular disease history Unstable medical conditions (cancer)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bariatric Surgery Candidates<br>Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH & Shands Hospital. | Procedure: Bariatric Surgery Candidates<br>* Participants who are intending to have bariatric surgery for weight loss<br>|
| Non surgical/Community volunteers<br>Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss | Other: Non surgical/Community volunteers<br>* Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weightloss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function