Diabetes, Weight Loss
Conditions
Keywords
Weight loss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function, tVNS intervention post-surgery
Brief 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 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.
Interventions
BEHAVIORALtVNS
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.
PROCEDUREComplete 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.
PROCEDUREAnterior 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.
Sponsors
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain inflammation - MRS | 18 months | Utilizing MRS the study seeks to understand changes in brain inflammation between the groups |
| Cognitive functioning - Global functioning score | 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. |
Countries
United States
Contacts
CONTACTKeyanni J Johnson
CONTACTRonald Cohen, PhD
PRINCIPAL_INVESTIGATOREric Porges, PhD
University of Florida
Outcome results
None listed