Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Change in BOLD fMRI Signal
研究概览
简要总结
This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.
详细描述
There will be two groups of people studied:
One group has chosen (independently of this research study) to have weight loss surgery to help them lose weight.
Another group will not choose to have any weight loss surgery. All research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will have an MRI Brain Scan at those same times also to look at 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
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Body Mass Index >35
- •Diabetes or no diabetes
- •Compatible with MRI Scanning
- •Willing to give a small blood sample on 3 occasions
- •Capable of providing informed consent
排除标准
- •Prior neurological disorder
- •Mini Mental Status Exam score
- •Major psychiatric disturbance (schizophrenia, chronic intractable depression,
- •Coronary revascularization, peripheral vascular disease
- •Severe cardio vascular disease history
- •Unstable medical conditions (cancer)
结局指标
主要结局
Change in BOLD fMRI Signal
时间窗: Change from baseline at 18 months
Brain activation changes will change in the frontal cortex and hippocampus. * z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions * a value of \< 0 suggests a weakening of the connections between brain areas; and a value of \> 0 suggests a strengthening of the connections between brain areas * A value of r=0 indicates that two brain regions were functionally disconnected
次要结局
未报告次要终点