Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Brain inflammation - MRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Prior or current neurological disorder
- •Major psychiatric disturbance
- •Unstable medical conditions (cancer)
- •MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
研究组 & 干预措施
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.
干预措施: tVNS (Behavioral)
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.
干预措施: Anterior Vagotomy (Procedure)
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
干预措施: tVNS (Behavioral)
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
干预措施: Complete Vagotomy (Procedure)
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.
干预措施: Anterior Vagotomy (Procedure)
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.
干预措施: Complete Vagotomy (Procedure)
结局指标
主要结局
Brain inflammation - MRS
时间窗: 18 months
Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
Cognitive functioning - Global functioning score
时间窗: 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.
次要结局
未报告次要终点