Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- changes of Islet β-cell functions from baseline
研究概览
简要总结
Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism of intensive lifestyle intervention to PCOS.
详细描述
We designed a non randomized control study to compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment We planed to enroll 48 patients.Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria. Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin> 11%, triglycerides >600 mg/dl).
Then we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1 group, metformin group and acarbose group, and each group 12 samples. Each group use specific treatment(showed as the group name) 3 months. Before and after the intervention, the blood samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood chemistry for liver and kidney function ect, as well as the image examinations.
We will compare the data of each patient, finally identify the treatment effect and mechanism of intensive lifestyle intervention to PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 14 Years 至 50 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria.
排除标准
- •Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin> 11%, triglycerides >600 mg/dl).
研究组 & 干预措施
intensive lifestyle intervention
3 months intensive lifestyle intervention, including low GI diet and exercise.
干预措施: intensive lifestyle intervention (Behavioral)
GLP-1 Receptor Agonists
3 months GLP-1 Receptor Agonists treatment
干预措施: GLP-1 Receptor Agonists (Drug)
metformin
3 months metformin treatment
干预措施: Metformin (Drug)
acarbose
3 months acarbose treatment
干预措施: Acarbose (Drug)
结局指标
主要结局
changes of Islet β-cell functions from baseline
时间窗: up to 12 weeks
Insulin and blood glucose levels
次要结局
- Incretin(up to 12 weeks)
- Intra-abdominal fat distribution(up to 12 weeks)
- Sex Hormone(up to 12 weeks)
