Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions

Study Overview
=================
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.

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid
* Dietary Supplement: Folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Folic acid<br> | Dietary Supplement: Folic acid<br>* Folic acid (200 mcg); 2 x die<br>|
| Experimental: Inofolic Combi<br> | Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid<br>* Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Evaluation of glycemia and insulinemia levels | At 6 months | 
| Homeostasis Model Assessment (HOMA-index) |  | At 6 months | 
| Sex hormone binding globulin (SHBG) test |  | At 6 months | 
| Androstenediol level test |  | At 6 months | 
| Androstenedione level test |  | At 6 months | 
| Free Androgen Index (FAI) level test |  | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) |  | At 6 months | 
| 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 | Ovarian ultrasound scan for the assessment of size and morphology | 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 | 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 | At 6 months | 
| Estradiol (E2) level test | Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle | At 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Metabolic disorders, Ovarian functionality, Myo-inositol, D-chiro-inositol