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RECRUITINGINTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - Prior or current neurological disorder - Major psychiatric disturbance - Unstable medical conditions (cancer) - MRI contraindications (claustrophobia, metal implants, waist/torso circumference) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

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