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

NCT01791647 | Completed

• 1 other identifier: 000102011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome; myoinositol; metformin; glucose-insulinemic metabolism; menstrual pattern; insulin-lowering therapies

Outcome Measures

Primary Outcomes (1)

• number of cycles

  six months

Secondary Outcomes (1)

• effects of two therapies on glyco-insulinemic metabolism

  six months

Study Arms (2)

myo-inositol

ACTIVE COMPARATOR

1500 mg/day myoinositol

Drug: myoinositol 1500 mg

metformin

ACTIVE COMPARATOR

1500 mg/day of metformin

Drug: metformin 1500 mg

Interventions

metformin 1500 mg DRUG

metformin

myoinositol 1500 mg DRUG

myo-inositol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
• BMI\>25 kg/m2;
• age 18-35 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin; Inositol

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: February 15, 2013
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

IT (1)