DiabetesNCT06861790
WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
A study testing tVNS, Complete Vagotomy and Anterior Vagotomy in people with Diabetes and Weight Loss, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Weight Loss
- What is being tested?
- tVNS, Complete Vagotomy and Anterior Vagotomy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior or current neurological disorder
- Major psychiatric disturbance
- Unstable medical conditions (cancer)
- MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida - College of Public Health and Health Professions
Gainesville, Florida, 32611
Keyanni Johnson, 352-294-5816, kjjohnson@ufl.edu
Ronald Cohen, PhD
About this study
Official title: Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
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.
Read the 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.
- Conditions
- Diabetes, Weight Loss
- Being tested
- tVNS, Complete Vagotomy, Anterior Vagotomy
- Keywords
- Weight loss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function, tVNS intervention post-surgery
- Medical subject headings
- Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNSBehavioural
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 VagotomyProcedure or surgery
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 VagotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| tVNS + anterior vagotomy | Experimental | 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. Receives: Behavioral: tVNS; Procedure: Anterior Vagotomy |
| tVNS + complete vagotomy | Experimental | 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 Receives: Behavioral: tVNS; Procedure: Complete Vagotomy |
| Sham + anterior vagotomy | Sham comparator | 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. Receives: Procedure: Anterior Vagotomy |
| Sham + complete vagotomy | Sham comparator | 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. Receives: Procedure: Complete Vagotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain inflammation - MRS
Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
Measured: 18 months
Cognitive functioning - Global functioning score
Utilizing a battery of cognitive tests the study seeks to determine changes in cognitive functioning. This can be determined by computing the Global functioning score on the battery of measures.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start10 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Porges, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861790
- Sponsor's protocol ID
- IRB202301845
- Other IDs
- R01DK099334
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
- ClinicalTrials.gov ID
- NCT06861790
- Acronym / sponsor ID
- IRB202301845
- Conditions
- Diabetes, Weight Loss
- Keywords
- Weight loss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function, tVNS intervention post-surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tVNS + anterior vagotomy | Experimental | Behavioral: tVNS, Procedure: Anterior VagotomyThis 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 + complete vagotomy | Experimental | Behavioral: tVNS, Procedure: Complete VagotomyThis arm will receive transcutaneous vagus nerve stimulation and a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery |
| Sham + anterior vagotomy | Sham comparator | Procedure: Anterior VagotomyThis 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. |
| Sham + complete vagotomy | Sham comparator | Procedure: Complete VagotomyThis 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Prior or current neurological disorder
- Major psychiatric disturbance
- Unstable medical conditions (cancer)
- MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNSThough 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. | Behavioural | tVNS + anterior vagotomy, tVNS + complete vagotomy |
| Complete VagotomyParticipants 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 or surgery | Sham + complete vagotomy, tVNS + complete vagotomy |
| Anterior VagotomyParticipants 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 or surgery | Sham + anterior vagotomy, tVNS + anterior vagotomy |
Primary outcome
Brain inflammation - MRS
Time frame: 18 months
Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
Cognitive functioning - Global functioning score
Time frame: 18 months
Utilizing a battery of cognitive tests the study seeks to determine changes in cognitive functioning. This can be determined by computing the Global functioning score on the battery of measures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Porges, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS, Complete Vagotomy and Anterior Vagotomy in people with Diabetes and Weight Loss, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyanni J Johnson (3522945618, kjjohnson@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain inflammation - MRS (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.