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NCT06861790 | RECRUITING | Diabetes

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

Condition or disease

Diabetes

Weight Loss

Intervention/treatment

tVNS

Complete Vagotomy

Anterior Vagotomy

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : DOUBLE
Primary Purpose : OTHER
Official Title : Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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)
WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Location Details

NCT06861790

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Locations

RECRUITING

United States, Florida

University of Florida - College of Public Health and Health Professions

Gainesville, Florida, United States, 32611