The WISE (Weightloss Intervention Surgical Effects) Brain Study

Completed

• Conditions: Diabetes; Weightloss
• Interventions: Other: Non surgical/Community volunteers; Procedure: Bariatric Surgery Candidates

• Registration Number: NCT02137070
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Start: 2014-08
• Primary Completion: 2022-11
• Study Completion: 2022-11
• Results First Submitted: 2024-07-18
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Results First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non surgical/Community volunteers	Non surgical/Community volunteers	Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Bariatric Surgery Candidates	Bariatric Surgery Candidates	Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH \& Shands Hospital.

Primary Outcome Measures

Name	Time	Method
Change in BOLD fMRI Signal	Change from baseline at 18 months	Brain activation changes will change in the frontal cortex and hippocampus.; * z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions; * a value of \< 0 suggests a weakening of the connections between brain areas; and a value of \> 0 suggests a strengthening of the connections between brain areas; * A value of r=0 indicates that two brain regions were functionally disconnected

Trial Locations

Locations (1)

University of Florida - College of Public Health and Health Professions; 🇺🇸 Gainesville, Florida, United States