Clinical trial NCT02137070: The WISE (Weightloss Intervention Surgical Effects) Brain Study
Official title: Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Weightloss
Keywords: Weightloss and brain function
Effects of bariatric surgery on brain function
Reduced glucose insulin changes and brain function
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-05-13
Enrollment: 197
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in BOLD fMRI Signal
timeFrame: Change from baseline at 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida - College of Public Health and Health Professions
state: Florida
Study officials:
affiliation: University of Florida
name: Ronald A Cohen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernando HJ, Cohen RA, Gullett JM, Friedman J, Ayzengart A, Porges E, Woods AJ, Gunstad J, Ochoa CM, Cusi K, Gonzalez-Louis R, Donahoo WT. Neurocognitive Deficits in a Cohort With Class 2 and Class 3 Obesity: Contributions of Type 2 Diabetes and Other Comorbidities. Obesity (Silver Spring). 2019 Jul;27(7):1099-1106. doi: 10.1002/oby.22508. Epub 2019 May 22.