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
- 200
- 主要终点
- Menstrual cycles
研究概览
简要总结
This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.
详细描述
This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve gastrectomy in obese patients with Polycystic Ovary Syndrome（PCOS). About 100 obese patients with PCOS and 100 simple obese patients (without complications) were enrolled.
All PCOS 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 were measured baseline and postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ranged from 18~45 years old,
- •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
- •outside of the 18-45 age range;
- •secondary obesity caused by endocrine disorders;
- •history of more than one bariatric procedure;
- •severe hepatic, renal or heart dysfunction;
- •mental illnesses or intellectual disability.
- •pregnancy or lactation
- •contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,
结局指标
主要结局
Menstrual cycles
时间窗: 3 years
the total number of menstrual periods in the last year
次要结局
- FT(3 years)
- LDL-C(3 years)
- FGF-19(3 years)
- FBG(3 years)
- AD(3 years)
- HOMA-IR(3 years)
- HbA1c (%)(3 years)
- PRL(3 years)
- PINS(3 years)
- SHBG(3 years)
- DHEAS(3 years)
- FGL-1(3 years)
- BMI(3 years)
- PBG(3 years)
- FINS(3 years)
- ALT(3 years)
- UA(3 years)
- HDL-C(3 years)
- FSH(3 years)
- E2(3 years)
- ZAG(3 years)
- Waist/hip Ratio(3 years)
- TT(3 years)
- AST(3 years)
- LH(3 years)
- TC(3 years)
- Fertility(3 years)
- CR(3 years)
- TG(3 years)
研究者
Zhang Manna
Director
Shanghai 10th People's Hospital