Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.
Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS phenotype A
- •BMI≥ 25kg/m2
- •metformin 1000mg twice a day for at least one year
排除标准
- •PCOS phenotype B, C, D
- •BMI <25kg/m2
- •had been treated with spironolactone or oral contraceptives alone or in combination with metformin
- •had history of bariatric surgery
- •became pregnant during the observation period
- •had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year
结局指标
主要结局
body weight
时间窗: The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
Primary outcome was change in body weight.
menstrual frequency
时间窗: The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.
Primary outcome was change in menstrual frequency.
free testosterone
时间窗: The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
Primary outcome was change in levels of free testosterone.
diabetes mellitus
时间窗: The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.
Primary outcome was development of diabetes mellitus.
次要结局
未报告次要终点
研究者
Andrej Janez
Clinical professor
University Medical Centre Ljubljana