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

Phase 4

Completed

• Conditions: PCOS
• Interventions: Dietary Supplement: Folic acid; Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid

• Registration Number: NCT01626443
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-22
• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folic acid	Folic acid	-
Inofolic Combi	Myo-inositol + D-chiro-inositol + Folic acid	-

Primary Outcome Measures

Name	Time	Method
Sex hormone binding globulin (SHBG) test	At 6 months
Score hirsutism (Ferriman-Gallwey classification)	At 6 months
Serum progesterone	At 6 months
Testosterone level test	At 6 months
Homeostasis Model Assessment (HOMA-index)	At 6 months
Androstenediol level test	At 6 months
Androstenedione level test	At 6 months
Free Androgen Index (FAI) level test	At 6 months
Menstrual cycle restoration	At 6 months
Oral glucose tolerance test (OGTT)	At 6 months	Evaluation of glycemia and insulinemia levels

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

University of Pisa - Department of Endocrinology; 🇮🇹 Pisa, Italy