WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tVNS, Complete Vagotomy, Anterior Vagotomy.
- Who it may be relevant to
- Registry conditions: Diabetes, Weight Loss. Basic parameters: 20 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
Overview
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.
Detailed 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.
Interventions
- Behavioral tVNS
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. - Procedure Complete Vagotomy
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. - Procedure Anterior Vagotomy
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 outcome measures
- Brain inflammation - MRS [Time frame: 18 months]
- Cognitive functioning - Global functioning score [Time frame: 18 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Florida - College of Public Health and Health Professions — Gainesville
Identifiers
NCT: NCT06861790 · IRB202301845 · R01DK099334