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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: metformin 1500 mg; Drug: myoinositol 1500 mg

• Registration Number: NCT01791647
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-03-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	metformin 1500 mg	1500 mg/day of metformin
myo-inositol	myoinositol 1500 mg	1500 mg/day myoinositol

Primary Outcome Measures

Name	Time	Method
number of cycles	six months

Secondary Outcome Measures

Name	Time	Method
effects of two therapies on glyco-insulinemic metabolism	six months	Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy