Effects of Bariatric Surgery on Different Compositions of Trunk Fat and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change from Baseline Visceral Fat Area at 3 months after bariatric surgery
研究概览
简要总结
This is a prospective, single-center, observational study to explore effects of bariatric surgery on different compositions of trunk fat and mechanisms.
详细描述
This is a prospective, single-center, observational study to explore effects of bariatric surgery on different compositions of trunk fat and mechanisms. The primary outcome is effects of bariatric surgery on different compositions of trunk fat evaluated with MRI for patients pending bariatric surgery before and 3 months after surgery. The secondary outcome is the associations of trunk fat reduction with improvement in metabolism indicators. Before patients are enrolled in this observational study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the study. Patients who meet the conditions of the study will be required to sign an informed consent form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of >27.5 kg/m2 with T2DM;
- •BMI of >32.5 kg/m2 with or without metabolic syndrome;
- •Age 18-65 years old;
- •T2DM duration < 15 years.
排除标准
- •Previous history of pancreatitis or pancreatic surgery;
- •Serious T2DM complications or organic diseases;
- •Alcohol addiction;
- •Uncontrolled mental illness.
结局指标
主要结局
Change from Baseline Visceral Fat Area at 3 months after bariatric surgery
时间窗: Baseline and 3 months after sugery
Change from baseline visceral fat area (unite in cm3) evaluated with MRI at 3 months after bariatric surgery.
Change from Baseline Liver Fat Percentage at 3 months after bariatric surgery
时间窗: Baseline and 3 months after sugery
Change from baseline liver fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.
Change from Baseline Subcutaneous Fat Area at 3 months after bariatric surgery
时间窗: Baseline and 3 months after sugery
Change from baseline subcutaneous fat area (unite in cm3) evaluated with MRI at 3 months after bariatric surgery.
Change from Baseline Pancreatic Fat Percentage at 3 months after bariatric surgery
时间窗: Baseline and 3 months after sugery
Change from baseline pancreatic fat percentage (unite in %) evaluated with MRI at 3 months after bariatric surgery.
次要结局
- Correlation coefficient of trunk fat change with change in metabolism indicators(Baseline and 3 months after sugery)