NCT Number: NCT06861790
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.
Interested in participating?
Request Info20 year–75 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
Location status: Recruiting
Crystal Johnson-Mann, MD
SUB_INVESTIGATOR
Eric Porges, PhD
SUB_INVESTIGATOR
John Williamson, PhD
SUB_INVESTIGATOR
Kathryn Ross, PhD
SUB_INVESTIGATOR
Keyanni Johnson
CONTACT
Ronald Cohen, PhD
PRINCIPAL_INVESTIGATOR
Somnath Datta, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 18 months
Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
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.
Contact information is provided by the study sponsor or research team.
Keyanni J Johnson
CONTACT
Ronald Cohen, PhD
CONTACT
University of Florida
Other
Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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