WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
University of Florida
120 participants
Nov 10, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- Prior or current neurological disorder
- Major psychiatric disturbance
- Unstable medical conditions (cancer)
- MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06861790