The WISE (Weightloss Intervention Surgical Effects) Brain Study

Overview

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.

Full Title of Study: “Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2022

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.

Interventions

  • Procedure: Bariatric Surgery Candidates
    • Participants who are intending to have bariatric surgery for weight loss
  • Other: Non surgical/Community volunteers
    • Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in BOLD fMRI signal
    • Time Frame: Change from baseline at 18 months
    • Brain activation changes will change in the frontal cortex and hippocampus.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald A Cohen, PHD, Principal Investigator, University of Florida
  • Overall Contact(s)
    • Alexa Study Coordinator, 352-294-5837, wisestudy@phhp.ufl.edu

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