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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
46
Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die
Folic acid (200 mcg); 2 x die
University of Pisa - Department of Endocrinology
Pisa, Italy
Menstrual cycle restoration
Time frame: At 6 months
Score hirsutism (Ferriman-Gallwey classification)
Time frame: At 6 months
Serum progesterone
Time frame: At 6 months
Testosterone level test
Time frame: At 6 months
Oral glucose tolerance test (OGTT)
Evaluation of glycemia and insulinemia levels
Time frame: At 6 months
Homeostasis Model Assessment (HOMA-index)
Time frame: At 6 months
Sex hormone binding globulin (SHBG) test
Time frame: At 6 months
Androstenediol level test
Time frame: At 6 months
Androstenedione level test
Time frame: At 6 months
Free Androgen Index (FAI) level test
Time frame: At 6 months
Body Mass Index (BMI)
Time frame: At 6 months
Change from baseline in diastolic blood pressure levels
Time frame: At 6 months
Change from baseline in systolic blood pressure levels
Time frame: At 6 months
Number of patients with abnormal ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Time frame: At 6 months
Luteinizing Hormone (LH) level test
Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
Time frame: At 6 months
Follicle Stimulating Hormone (FSH) level test
Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
Time frame: At 6 months
Estradiol (E2) level test
Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle
Time frame: At 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.