Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Free testosterone variation
研究概览
简要总结
The aim of this double-blinded, three-armed randomized controlled trial (RCT) is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome (PCOS).
The study population is composed of 90 women with PCOS (diagnosed according to the Rotterdam criteria). Subjects are randomized to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone).
At recruitment and after 6 months of treatment, the following data are collected:
- clinical data: height, weight, BMI, waist and hip circumference, blood pressure, Ferriman Gallwey Score, menstrual diary
- endocrine parameters (serum total and free testosterone levels, SHBG levels)
- metabolic profile: glycemia and insulinemia at fasting and after oral glucose tolerance test (OGTT), serum lipids
- insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
- ovarian ultrasound data. Furthermore, ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples.
The primary outcome of the study is the serum free testosterone variation after 6 months of treatment. Secondary outcomes are the variations of lipid profile, ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment.
详细描述
The aim of this study is to evaluate the effects of a 6 months treatment with inositol, alone or associated with alpha-lipoic acid, in women with PCOS. This is a double blinded, three-armed RCT.
The study population is composed of 90 women with PCOS, recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata (AOUI), Verona.
After recruitment, subjects are randomly assigned to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone). Randomisation is stratified by BMI category (3 categories 18<BMI<25, 25≥BMI<30, 30≥BMI<35 Kg/m2); randomisation list is generated by the statistical software Stata 13.1.
At baseline and after 6 months of treatment, the following data are collected:
- clinical examination: family and personal medical history, menstrual diary, physical examination including height, weight, waist and hip circumferences, blood pressure and hirsutism score (modified Ferriman-Gallwey score)
- total and free testosterone and sex hormone binding globulin (SHBG) blood levels, evaluated in the early follicular phase or after 3 months of amenorrhea
- metabolic profile: glycemia and insulinemia at fasting and after 2h OGTT, serum lipids (total cholesterol, HDL-cholesterol and triglycerides). Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
- insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique. Data obtained with this test will be normalized for lean mass, measured by bioelectrical impedance. The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline (M-value < 8.6 mg/kg min).
- Chronic inflammation markers (CRP)
- Ovarian ultrasound evaluation, including measurement of the 3 diameters for ovarian volume calculation, and follicle count. The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI, Verona.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female subjects
- •age between 18 and 40 years old
- •diagnosed with PCOS (according to the Rotterdam criteria)
- •not use of possible interfering drugs in the 4 previous months
- •written informed consent.
排除标准
- •BMI ≥ 35 kg/m2
- •acute illnesses
- •chronic kidney or hepatic disease
- •taking possible interfering drugs
研究组 & 干预措施
Inositol + alpha lipoic acid
Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
干预措施: Inositol + alpha lipoic acid (Dietary Supplement)
Folic acid
Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
干预措施: Folic acid (placebo comparator) (Dietary Supplement)
Inositol
Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
干预措施: Inositol (Dietary Supplement)
结局指标
主要结局
Free testosterone variation
时间窗: 6 months
Free testosterone variation after 6 months of treatment
次要结局
- Lipid profile variation(6 months)
- Number of ovulations in the last 4 months of treatment(4 months)
- Insulin sensitivity variation(6 months)
- Ovarian morphology variation(6 months)
研究者
Paolo Moghetti
Professor
Universita di Verona