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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06861790
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • 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.
  • 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
  • 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.
  • 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.

Primary Outcome Measure

Brain inflammation - MRS [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida - College of Public Health and Health ProfessionsGainesvilleFlorida32611
Keyanni Johnson
[email protected]
352-294-5816
Ronald Cohen, PhD (PRINCIPAL_INVESTIGATOR)
Eric Porges, PhD (SUB_INVESTIGATOR)
John Williamson, PhD (SUB_INVESTIGATOR)
Somnath Datta, PhD (SUB_INVESTIGATOR)
Kathryn Ross, PhD (SUB_INVESTIGATOR)
Crystal Johnson-Mann, MD (SUB_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida - College of Public Health and Health Professions· Gainesville, FL

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