Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Menstrual cycle restoration
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels.
The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 14-40 years
- •BMI > 28
- •Hyperinsulinemia
排除标准
- •Pre-existing secondary endocrine and metabolic disorders
- •Pre-existing secondary adrenal disorders
- •Pharmacologic treatment in the last 3 months before entering the study
- •Pregnancy
研究组 & 干预措施
Folic acid
干预措施: Folic acid (Dietary Supplement)
Inofolic Combi
干预措施: Myo-inositol + D-chiro-inositol + Folic acid (Dietary Supplement)
结局指标
主要结局
Menstrual cycle restoration
时间窗: At 6 months
Oral glucose tolerance test (OGTT)
时间窗: At 6 months
Evaluation of glycemia and insulinemia levels
Score hirsutism (Ferriman-Gallwey classification)
时间窗: At 6 months
Serum progesterone
时间窗: At 6 months
Testosterone level test
时间窗: At 6 months
Homeostasis Model Assessment (HOMA-index)
时间窗: At 6 months
Sex hormone binding globulin (SHBG) test
时间窗: At 6 months
Androstenediol level test
时间窗: At 6 months
Androstenedione level test
时间窗: At 6 months
Free Androgen Index (FAI) level test
时间窗: At 6 months
次要结局
- Change from baseline in diastolic blood pressure levels(At 6 months)
- Change from baseline in systolic blood pressure levels(At 6 months)
- Number of patients with abnormal ovarian size and morphology(At 6 months)
- Luteinizing Hormone (LH) level test(At 6 months)
- Follicle Stimulating Hormone (FSH) level test(At 6 months)
- Estradiol (E2) level test(At 6 months)
- Body Mass Index (BMI)(At 6 months)