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

University of Florida

Status: Enrolling

Conditions: Weight Loss; Diabetes

Treatments: Procedure: Anterior Vagotomy; Behavioral: tVNS; Procedure: Complete Vagotomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06861790

R01DK099334 (U.S. NIH Grant/Contract)

IRB202301845

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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120 participants in 4 patient groups

tVNS + anterior vagotomy

Experimental group

Description:

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.

Treatment:

Behavioral: tVNS

Procedure: Anterior Vagotomy

tVNS + complete vagotomy

Experimental group

Description:

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

Treatment:

Procedure: Complete Vagotomy

Behavioral: tVNS

Sham + anterior vagotomy

Sham Comparator group

Description:

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.

Treatment:

Procedure: Anterior Vagotomy

Sham + complete vagotomy

Sham Comparator group

Description:

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.

Treatment:

Procedure: Complete Vagotomy