Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Menstrual cycle
研究概览
简要总结
The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months.
详细描述
The study will involve 60 women in the reproductive period, with a variable between 19 and 36 years old and diagnosed with polycystic ovary syndrome (PCOS), according to Rotterdam- European Society of Human Reproduction and Embryology (ESHRE) / American Society for Reproductive Medicine (ASRM) criteria defined in 2003 and revised in 2018, and insulin resistance (presence acanthosis nigricans) or glucose intolerance (fasting glycemia, glycated hemoglobin or 75g glycemic overload and blood glucose assessment after 2 hours). It is a comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin 850 mg, orally, twice a day; Group II (experiment) - they will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day.
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
- 19 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.
排除标准
- •Previous use of any hormonal treatment in the past three months;
- •Other causes of anovulation;
- •Gynecological or other associated conditions (endometriosis, adenomyosis or diabetes mellitus);
- •FSH (Follicle Stimulating Hormone) > 15 Ul / L (2nd to 5th day of the cycle);
- •Beta-hcG (human chorionic gonadotropin) positive (pregnancy).
研究组 & 干预措施
Myo-inositol
30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months.
干预措施: Myo-inositol (Drug)
Metformin
30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months
干预措施: Metformin (Drug)
结局指标
主要结局
Menstrual cycle
时间窗: 6 months
Analysis of period calendar.
Change in body mass index
时间窗: Every 3 months for up to 6 months
Body mass index (kg/m2) will be assessed every 3 months.
Change in glycated hemoglobin
时间窗: Every 3 months for up to 6 months
Glycated hemoglobin will be performed every 3 months.
Change in antral follicle count
时间窗: 6 months
Ultrasound of the ovaries will be done before and after treatment for antral follicle count (all follicles from 2 to 9 mm will be measured)
Change in glucose metabolism
时间窗: Every 3 months for up to 6 months
Glucose tolerance curve with insulin curve will be performed every 3 months.
Change in ultrasound of the ovaries
时间窗: 6 months
Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.
Change in body weight in kilograms
时间窗: Every 3 months for up to 6 months
Patients will be weighed every 3 months (measured in kilograms).
Change in Abdominal Circumference and Hip Circumference
时间窗: Every 3 months for up to 6 months
Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.
次要结局
- Homocysteine(6 months)
- Change in Lipid Profile(Every 3 months for up to 6 months)
- Hepatic steatosis(6 months)
- Chronic inflammatory process(6 months)
- Modified Ferriman-Gallwey Score(6 months)
- Assess adherence to treatment.(Every 3 months for up to 6 months)
- Side effects(Every 3 months for up to 6 months)
- Liver enzymes(6 months)
- C-reactive protein(6 months)
- Hormonal dosage (FSH, LH, progesterone, estradiol)(6 months)