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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK099334 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tVNS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain inflammation - MRS | Utilizing MRS the study seeks to understand changes in brain inflammation between the groups | 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. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keyanni J Johnson | Contact | 3522945618 | kjjohnson@ufl.edu | |
| Ronald Cohen, PhD | Contact | 352-295-5840 | roncohen@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric Porges, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida - College of Public Health and Health Professions | Recruiting | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Complete Vagotomy | Procedure | 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. |
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| Anterior Vagotomy | Procedure | 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. |
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| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |