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

NCT06861790 | Recruiting

• 2 other identifiers: IRB202301845R01DK099334
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Weight loss and brain function; Effects of bariatric surgery on brain function; Reduced glucose insulin changes and brain function; tVNS intervention post-surgery

Outcome Measures

Primary Outcomes (2)

• Brain inflammation - MRS

  Utilizing MRS the study seeks to understand changes in brain inflammation between the groups

  18 months

• Cognitive functioning - Global functioning score

  Utilizing a battery of cognitive tests the study seeks to determine changes in cognitive functioning. This can be determined by computing the Global functioning score on the battery of measures.

  18 months

Study Arms (4)

tVNS + anterior vagotomy

EXPERIMENTAL

This arm will receive transcutaneous vagus nerve stimulation and an anterior vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

Behavioral: tVNS; Procedure: Anterior Vagotomy

tVNS + complete vagotomy

EXPERIMENTAL

This arm will receive transcutaneous vagus nerve stimulation and a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery

Behavioral: tVNS; Procedure: Complete Vagotomy

Sham + anterior vagotomy

SHAM COMPARATOR

This arm will not receive transcutaneous vagus nerve stimulation and will receive an anterior vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

Procedure: Anterior Vagotomy

Sham + complete vagotomy

SHAM COMPARATOR

This arm will not receive transcutaneous vagus nerve stimulation and will receive a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

Procedure: Complete Vagotomy

Interventions

tVNS BEHAVIORAL

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.

tVNS + anterior vagotomy; tVNS + complete vagotomy

Complete Vagotomy PROCEDURE

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.

Sham + complete vagotomy; tVNS + complete vagotomy

Anterior Vagotomy PROCEDURE

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.

Sham + anterior vagotomy; tVNS + anterior vagotomy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior or current neurological disorder
• Major psychiatric disturbance
• Unstable medical conditions (cancer)
• MRI contraindications (claustrophobia, metal implants, waist/torso circumference)

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Florida - College of Public Health and Health Professions

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Porges, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyanni J Johnson

CONTACT

3522945618; kjjohnson@ufl.edu

Ronald Cohen, PhD

CONTACT

352-295-5840; roncohen@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 6, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2025-12

Locations

US (1)