Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Stromal/Cortical ratio in the ovary
研究概览
简要总结
Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.
Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.
In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.
In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women fulfilled two out of three diagnostic criteria for PCOS
排除标准
- •Women with pre-existing secondary endocrine disorders
- •Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
- •Women who received treatment with other drugs for the previous 6 months before entering the study.
研究组 & 干预措施
Insulin resistant patients
干预措施: Myo-inositol + Folic acid (Dietary Supplement)
Insulin resistant patients
干预措施: D-chiro-inositol, manganese, folic acid, vit B12 (Dietary Supplement)
Insulin resistant patients
干预措施: Folic acid, vit B12 (Drug)
Non-insulin resistant patients
干预措施: Myo-inositol + Folic acid (Dietary Supplement)
Non-insulin resistant patients
干预措施: D-chiro-inositol, manganese, folic acid, vit B12 (Dietary Supplement)
Non-insulin resistant patients
干预措施: Folic acid, vit B12 (Drug)
结局指标
主要结局
Stromal/Cortical ratio in the ovary
Antral follicle counts
Body Mass Index (BMI)
Menstrual cycle
Score acne (acne grading system by Cremoncini et al)
Score hirsutism (Ferriman-Gallwey score)
Alopecia
Oral Glucose Tolerance Test (OGTT)
Glucagon levels
C-peptide test
Myo-inositol serum concentration
D-chiro-inositol serum concentration
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Prolactin (PRL) levels test
Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Total and free testosterone levels
Sex hormone binding globulin (SHBG) test
17-Hydroxyprogesterone (17-OHP) levels
Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
delta 4-androstenedione levels
progesterone levels
Adrenocorticotropic Hormone (ACTH) stimulation test
Ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Endometrial thickness
Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.
次要结局
未报告次要终点