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

February 6, 2026 updated by: University of Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There will be one group of study participants.

The group will (independently of this research study) have weight loss surgery to help them with weight loss.

All research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will also undergo a non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention days post-surgery, for 30 days at home with the device that is provided.

The group will have an MRI Brain Scan at each time-point to study the changes in the structure and function of the brain tissue.

Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida - College of Public Health and Health Professions
        • Principal Investigator:
          • Ronald Cohen, PhD
        • Sub-Investigator:
          • Eric Porges, PhD
        • Sub-Investigator:
          • John Williamson, PhD
        • Sub-Investigator:
          • Somnath Datta, PhD
        • Sub-Investigator:
          • Kathryn Ross, PhD
        • Contact:
        • Sub-Investigator:
          • Crystal Johnson-Mann, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tVNS + anterior vagotomy
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
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: 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.
Experimental: tVNS + complete vagotomy
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
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.
Sham Comparator: Sham + anterior vagotomy
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
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 Comparator: Sham + complete vagotomy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain inflammation - MRS
Time Frame: 18 months
Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
18 months
Cognitive functioning - Global functioning score
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

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

Investigators

  • Principal Investigator: Eric Porges, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202301845
  • R01DK099334 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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