Shanghai Tenth People's Hospital，School of Medicine, Tongji University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Hepatic steatosis
研究概览
简要总结
This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.
详细描述
This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.
All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ranged from 16~65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. -
排除标准
- •secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.
结局指标
主要结局
Hepatic steatosis
时间窗: 3 years
hepatic steatosis assessed by FibroScan(CAP value and E value)
次要结局
- FT(3 years)
- Menstrual cycles(3 years)
- TT(3 years)
- FINS(3 years)
- Fertility(3 years)
- Waist/hip Ratio(3 years)
- FBG(3 years)
- ALT(3 years)
- UA(3 years)
- HOMA-IR(3 years)
- SHBG(3 years)
- DHEAS(3 years)
- LDL-C(3 years)
- BMI(3 years)
- PBG(3 years)
- PINS(3 years)
- AST(3 years)
- HbA1c (%)，(3 years)
- HDL-C(3 years)
研究者
Shen Qu
Professor
Shanghai 10th People's Hospital