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临床试验/NCT02446834
NCT02446834已完成不适用

Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

3 months intensive lifestyle intervention, including low GI diet and exercise.

干预措施: intensive lifestyle intervention (Behavioral)

GLP-1 Receptor Agonists

Experimental

3 months GLP-1 Receptor Agonists treatment

干预措施: GLP-1 Receptor Agonists (Drug)

metformin

Experimental

3 months metformin treatment

干预措施: Metformin (Drug)

acarbose

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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