Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
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
- number of cycles
研究概览
简要总结
The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
- •BMI>25 kg/m2;
- •age 18-35 years.
排除标准
- •pregnancy;
- •significant liver or renal impairment;
- •other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs);
- •neoplasms;
- •unstable mental illness;
- •diagnosis of diabetes mellitus or impaired glucose tolerance;
- •use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.
研究组 & 干预措施
myo-inositol
1500 mg/day myoinositol
干预措施: myoinositol 1500 mg (Drug)
metformin
1500 mg/day of metformin
干预措施: metformin 1500 mg (Drug)
结局指标
主要结局
number of cycles
时间窗: six months
次要结局
- effects of two therapies on glyco-insulinemic metabolism(six months)
研究者
Maurizio Guido
principal investigator
Catholic University of the Sacred Heart