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

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

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 Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: myoinositol 1500 mg; Drug: metformin 1500 mg

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Catholic University Of Sacred Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of cycles	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	six months

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: metformin; Polycystic ovary syndrome; menstrual pattern; myoinositol; glucose-insulinemic metabolism; insulin-lowering therapies
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Metformin; Inositol
• Other Study ID Numbers: 000102011