WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Not Applicable

Not yet recruiting

• Conditions: Diabetes; Weight Loss

• Registration Number: NCT06861790
• Lead Sponsor: University of Florida

Brief Summary

The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery.

Detailed Description

There will be one group of study participants.

The group will (independently of this research study) have weight loss surgery to help them with weight loss.

All research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will also undergo a non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention days post-surgery, for 30 days at home with the device that is provided.

The group will have an MRI Brain Scan at each time-point to study the 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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Between age: 20-75 yrs, English speaking, Physically mobile
• Body Mass Index (BMI) >35 kg before surgery
• Compatible of MRI Scanning
• Willing to give a small blood sample
• Capable of providing informed consent

Exclusion Criteria

• Prior or current neurological disorder
• Major psychiatric disturbance
• Unstable medical conditions (cancer)
• MRI contraindications (claustrophobia, metal implants, waist/torso circumference)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Brain inflammation - MRS	18 months	Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
Cognitive functioning - Global functioning score	18 months	Utilizing a battery of cognitive tests the study seeks to determine changes in cognitive functioning. This can be determined by computing the Global functioning score on the battery of measures.

Trial Locations

Locations (1)

University of Florida - College of Public Health and Health Professions; 🇺🇸 Gainesville, Florida, United States