WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
NCT ID: NCT06861790
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-11-10
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
DOUBLE
Study Groups
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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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Major psychiatric disturbance
* Unstable medical conditions (cancer)
* MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
20 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Eric Porges, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida - College of Public Health and Health Professions
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB202301845
Identifier Type: -
Identifier Source: org_study_id
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