Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome

Catholic University of the Sacred Heart40 enrolled

Overview

The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

metformin 1500 mgDRUG

myoinositol 1500 mgDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003; * BMI\>25 kg/m2; * age 18-35 years. Exclusion Criteria: * pregnancy; * significant liver or renal impairment; * other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs); * neoplasms; * unstable mental illness; * diagnosis of diabetes mellitus or impaired glucose tolerance; * use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.

Locations (1)

Catholic University of Sacred Heart

Rome, Italy

Outcomes

Primary Outcomes

number of cycles

Time frame: six months

Secondary Outcomes

effects of two therapies on glyco-insulinemic metabolism

Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).

Time frame: six months

Data from ClinicalTrials.gov

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