Beijing Friendship Hospital Metabolic Surgery Clinical Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- the excess weight loss effect of metabolic surgery after 1year
研究概览
简要总结
Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be able to receive metabolic surgery (LSG or LRYGB)
排除标准
- •can not be able to understand and willing to participate in this registry with signature
结局指标
主要结局
the excess weight loss effect of metabolic surgery after 1year
时间窗: 1 year after surgery
Percent excess weight loss (%EWL), %EWL=\[(initial weight)-(post-op weight)\]/\[(initial weight)-(ideal weight)\] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
次要结局
- the glycemic control effect of metabolic surgery after 1 year(1 year after surgery)
- the excess weight loss effect of metabolic surgery with long-time follow-ups(10 years)
- the adverse events rate of metabolic surgery(30 days after surgery)
- the glycemic control effect of metabolic surgery with long-time follow-ups(10 years)
研究者
Zhongtao Zhang
Director of general surgery, principal investigator
Beijing Friendship Hospital