The WISE (Weightloss Intervention Surgical Effects) Brain Study (WISEBrain)

March 13, 2024 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida - College of Public Health and Health Professions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Ronald A Cohen, PHD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimated)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400034-N
  • 1R01DK099334-01A1 (U.S. NIH Grant/Contract)
  • OCR15981 (Other Identifier: Universiy of Florida)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Bariatric Surgery Candidates

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe