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

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.

Conditions

• Diabetes
• Weight Loss

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Eric Porges, PhD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-10

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States

Study Locations