RecruitingNot ApplicableNCT06861790

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

Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)


Sponsor

University of Florida

Enrollment

120 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how bariatric (weight loss) surgery affects brain function, by scanning participants' brains before and after surgery to better understand the neurological effects of significant weight loss. **You may be eligible if...** - You are between 20 and 75 years old - You speak English and are physically mobile - Your BMI is greater than 35 before surgery - You are able to undergo MRI scanning - You are willing to provide a small blood sample **You may NOT be eligible if...** - You have a current or prior neurological disorder - You have a major psychiatric condition - You have unstable medical conditions such as active cancer - You have MRI contraindications (e.g., claustrophobia, metal implants, or a very large body circumference) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALtVNS

Though we will be utilizing a tVNS (Transcutaneous Vegus Nerve Stimulation) device this study is not a device study. The device being used is being done so under its approved usage. The intervention utilizes a non-invasive process to stimulate the Vagus nerve using very small electrical currents. This intervention is completed daily for one month.

PROCEDUREComplete Vagotomy

Participants will not be receiving bariatric surgery as an intervention of this study. Instead, the study will enroll patients already planning on undergoing the surgery. The surgeon will utilize one of two surgical approaches which will be observed in this study.

PROCEDUREAnterior Vagotomy

Participants will not be receiving bariatric surgery as an intervention of this study. Instead, the study will enroll patients already planning on undergoing the surgery. The surgeon will utilize one of two surgical approaches which will be observed in this study.


Locations(1)

University of Florida - College of Public Health and Health Professions

Gainesville, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06861790


Related Trials