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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 20 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 30 days
- Procedures mentioned: MRI scans, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how weight loss and better diabetes control after weight-loss surgery affect the brain and thinking. It also tests whether gentle nerve stimulation through the skin, started 30 days after surgery, helps. It is for adults ages 20–75 with a BMI over 35 before surgery; the study does not pay for the surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 20–75 years old.
- Speak English.
- Be able to move around.
- Have a body mass index (BMI) over 35 before surgery. BMI measures weight compared with height.
- Be able to safely have an MRI, a scan that takes pictures inside the body.
- Be willing to give a small blood sample.
- Be able to understand the study and agree to take part.
Who can't join
- Have or have had a disorder of the brain or nerves.
- Have a serious mental health condition.
- Have an unstable medical condition, such as cancer.
- Cannot have an MRI because of fear of tight spaces, metal implants, or waist or upper-body size.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
FL
- University of Florida - College of Public Health and Health Professions · Gainesville, FL 32611Keyanni Johnson · Study contact · 352-294-5816 · kjjohnson@ufl.eduRonald Cohen, PhD · Principal investigatorEric Porges, PhD · Sub-investigatorJohn Williamson, PhD · Sub-investigatorMore trials in Gainesville