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

University of Florida

Status: Completed

Conditions: Diabetes; Weightloss

Treatments: Procedure: Bariatric Surgery Candidates; Other: Non surgical/Community volunteers

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02137070

OCR15981 (Other Identifier)

1R01DK099334-01A1 (U.S. NIH Grant/Contract)

IRB201400034-N

Details and patient eligibility

About

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 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.

Enrollment: 197 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

197 participants in 2 patient groups

Bariatric Surgery Candidates

Description:

Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH \& Shands Hospital.

Treatment:

Procedure: Bariatric Surgery Candidates

Non surgical/Community volunteers

Description:

Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss

Treatment:

Other: Non surgical/Community volunteers