跳至主要内容
临床试验/NCT04151459
NCT04151459Unknown不适用

Effect of Laparoscopic Sleeve Gastrectomy (LSG) on Live Birth Rate of Offspring in Polycystic Ovarian Syndrome (PCOS) Patients With Severely Obese

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年1月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
18
试验地点
1
主要终点
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.

研究概览

简要总结

This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring.

详细描述

The investigators designed a single center small sample exploratory study to clear the therapeutic effects of laparoscopic sleeve gastrectomy on live birth rate improvements of overweight/obese PCOS patients. The investigators plan to enroll 18 patients. Inclusion criteria: 1) Patients who are aged from 18 to 45, not menopause;2) have PCOS which is diagnosed according to 2003 Rotterdam criteria; 3) have been treated with behavioral and drugs intervention for 3 months but are ineffective; 4) have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome.

Patients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; surgical contraindications are excluded.

Then the investigators plan to perform laparoscopic sleeve gastrectomy . Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients are followed up every 3 months until the end of the program. All patients receive MRI plain scan of upper and lower abdomen, oral glucose tolerance test (OGTT) and insulin, C-peptide releasing test again every 6 months after the operation. One year after the operation, patients would be evaluated whether they are suitable for pregnancy preparation and record the pregnancy mode. After pregnancy, various indicators would be closely monitored, including maternal vitamin and trace element levels.The birth of children and the live birth rate would be recorded.

The investigators will compare the data and finally identify the treatment effect of laparoscopic sleeve gastrectomy on overweight/obese PCOS patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • aged from 18 to 45, not menopause have PCOS which is diagnosed according to 2003 Rotterdam criteria have been treated with behavioral and drugs intervention for 3 months but are ineffective have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome

排除标准

  • Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) high blood pressure (>160/100mmHg) active infection secondary diabetes pregnancy alcohol abuse surgical contraindications

研究组 & 干预措施

Laparoscopic sleeve gastrectomy

Experimental

Laparoscopic sleeve gastrectomy on severe obesity PCOS patients

干预措施: Metformin (Drug)

结局指标

主要结局

Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.

时间窗: up to 3 years

To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery

次要结局

  • Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients(up to 3 years)
  • Effects of metabolic surgery on intestinal flora of PCOS patients and progeny.(up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect of Metabolic Surgery on Live Birth Rate of... | 临床试验