The WISE (Weightloss Intervention Surgical Effects) Brain Study

Diabetes Clinical Trial

— WISEBrain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137070
• Other study ID #: IRB201400034-N
• Secondary ID: 1R01DK099334-01A
• Status: Completed
• Start date: August 2014
• Est. completion date: November 2022

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Weight Loss
• Weightloss

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida - College of Public Health and Health Professions	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BOLD fMRI signal	Brain activation changes will change in the frontal cortex and hippocampus.	Change from baseline at 18 months