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NCT Number: NCT06861790

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

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.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida - College of Public Health and Health Professions

Gainesville, Florida, 32611, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Brain inflammation - MRS

    Time frame: 18 months

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

  2. 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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