PCOS
Conditions
Keywords
PCOS, Metabolic disorders, Ovarian functionality, Myo-inositol, D-chiro-inositol
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMyo-inositol + D-chiro-inositol + Folic acid
Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die
DIETARY_SUPPLEMENTFolic acid
Folic acid (200 mcg); 2 x die
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* PCOS * Women aged between 14-40 years * BMI \> 28 * Hyperinsulinemia
Exclusion criteria
* Pre-existing secondary endocrine and metabolic disorders * Pre-existing secondary adrenal disorders * Pharmacologic treatment in the last 3 months before entering the study * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homeostasis Model Assessment (HOMA-index) | At 6 months | — |
| Androstenedione level test | At 6 months | — |
| Free Androgen Index (FAI) level test | At 6 months | — |
| Menstrual cycle restoration | At 6 months | — |
| Score hirsutism (Ferriman-Gallwey classification) | At 6 months | — |
| Serum progesterone | At 6 months | — |
| Testosterone level test | At 6 months | — |
| Oral glucose tolerance test (OGTT) | At 6 months | Evaluation of glycemia and insulinemia levels |
| Sex hormone binding globulin (SHBG) test | At 6 months | — |
| Androstenediol level test | At 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Ovarian ultrasound scan for the assessment of size and morphology |
| Luteinizing Hormone (LH) level test | At 6 months | Analysis of LH levels should be performed between the 7th and the 10th day of the cycle |
| Follicle Stimulating Hormone (FSH) level test | At 6 months | Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle |
| Estradiol (E2) level test | At 6 months | Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle |
| Body Mass Index (BMI) | At 6 months | — |
Countries
Italy
Outcome results
None listed