Bariatric Surgery Effects on Brain Function in Obesity and Type 2 Diabetes
tVNS
+ Anterior Vagotomy
+ Complete Vagotomy
Body Weight+7
+ Body Weight Changes
+ Diabetes Mellitus
Other Study
Summary
Study start date: November 10, 2025
Actual date on which the first participant was enrolled.This study focuses on individuals who are undergoing weight loss surgery due to obesity and Type 2 Diabetes. It aims to investigate how this surgery affects brain functions related to thinking and memory. Obesity and diabetes can impact brain health, and this research seeks to understand the potential positive changes in brain structure and function following surgery. By exploring these changes, the study hopes to uncover important insights that could improve care and treatment strategies for those facing similar health challenges. Participants will have cognitive tests to assess their thinking and memory skills at the beginning of the study, 12 weeks later, and then at 18 months. They will also receive a device for a non-invasive procedure called transcutaneous vagal nerve stimulation (tVNS), which they will use at home for 30 days shortly after their surgery. Additionally, participants will undergo MRI scans at each stage to observe changes in their brain. Blood tests will be conducted to monitor sugar levels and other markers related to disease. These procedures aim to evaluate how surgery may influence both brain function and overall health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ShamGroup IV
ShamStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Florida - College of Public Health and Health Professions
Gainesville, United StatesOpen University of Florida - College of Public Health and Health Professions in Google Maps