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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT01791647

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: metformin 1500 mg Drug: myoinositol 1500 mg	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: myo-inositol 1500 mg/day myoinositol	Drug: myoinositol 1500 mg
Active Comparator: metformin 1500 mg/day of metformin	Drug: metformin 1500 mg

Arm

Intervention/Treatment

Active Comparator: myo-inositol

1500 mg/day myoinositol

Drug: myoinositol 1500 mg

Active Comparator: metformin

1500 mg/day of metformin

Drug: metformin 1500 mg

Outcome Measures

Primary Outcome Measures

number of cycles [six months]

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.