Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: t
View:
• 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
Locations
United States
Florida
University of Florida - College of Public Health and Health Professions
RECRUITING
Gainesville
Contact Information
Primary
Keyanni J Johnson
kjjohnson@ufl.edu
3522945618
Backup
Ronald Cohen, PhD
roncohen@ufl.edu
352-295-5840
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-09
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Florida