Nerve Stimulation for Weight Loss and Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Anterior Vagotomy, Complete Vagotomy, tVNS for weight loss and diabetes?
Research shows that vagotomy, a procedure that involves cutting the vagus nerve, can lead to weight loss in both animals and humans by reducing hunger and changing food intake habits. Some studies have observed significant weight decreases in patients with morbid obesity after vagotomy, suggesting it may help with weight management.12345
Is nerve stimulation for weight loss and diabetes safe for humans?
Nerve stimulation, including vagotomy, has been studied for various conditions and is generally considered safe, though some adverse events have been reported. In children, some experienced treatable side effects, and in adults, there were few complications, with one case of sudden death years after the procedure. Overall, it is tolerated well, but unforeseen surgeries may be needed.12367
How does the treatment Anterior Vagotomy, Complete Vagotomy differ from other treatments for weight loss and diabetes?
Anterior Vagotomy, Complete Vagotomy is unique because it involves cutting the vagus nerve, which can lead to weight loss by reducing hunger and altering food intake, unlike other treatments that may focus on diet, exercise, or medication. This approach is based on its effects on digestion and hormonal changes, which are not typically targeted by standard weight loss or diabetes treatments.12345
What is the purpose of this trial?
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.
Research Team
Eric Porges, PhD
Principal Investigator
University of Florida
Eligibility Criteria
The WISE-2B Brain Study is for individuals aged 20-75 with severe weight issues (BMI over 35) who are about to undergo bariatric surgery. Participants must be able to have an MRI scan, provide a blood sample, speak English, and move around on their own. People with claustrophobia, metal implants that affect MRI, neurological disorders, major psychiatric conditions or unstable medical situations like cancer cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Assessment
Participants undergo bariatric surgery and initial cognitive and MRI assessments
tVNS Intervention
Participants receive non-invasive transcutaneous vagal nerve stimulation for 30 days post-surgery
Follow-up Assessments
Participants are assessed on cognitive and brain function at 12 weeks and 18 months post-surgery
Treatment Details
Interventions
- Anterior Vagotomy
- Complete Vagotomy
- tVNS
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator