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RECRUITING
NCT06861790
NA

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

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-10

Completion Date

2027-12

Last Updated

2026-02-10

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

tVNS

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.

PROCEDURE

Complete 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.

PROCEDURE

Anterior 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