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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01791647
First received: March 12, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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 Intervention
Polycystic Ovary Syndrome
Drug: metformin 1500 mg
Drug: myoinositol 1500 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • number of cycles [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effects of two therapies on glyco-insulinemic metabolism [ Time Frame: six months ] [ Designated as safety issue: No ]
    Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).


Estimated Enrollment: 40
Study Start Date: June 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: myo-inositol
1500 mg/day myoinositol
Drug: myoinositol 1500 mg
Active Comparator: metformin
1500 mg/day of metformin
Drug: metformin 1500 mg

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791647

Contacts
Contact: Antonio Lanzone, Professor 063057794

Locations
Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Maurizio Guido, Medical Doctor    063057794      
Principal Investigator: Maurizio Guido, Medical Doctor         
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Maurizio Guido, principal investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01791647     History of Changes
Other Study ID Numbers: 000102011
Study First Received: March 12, 2012
Last Updated: February 12, 2013
Health Authority: Italy: Catholic University of Sacred Heart

Keywords provided by Catholic University of the Sacred Heart:
Polycystic ovary syndrome
myoinositol
metformin
glucose-insulinemic metabolism
menstrual pattern
insulin-lowering therapies

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Inositol
Metformin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 21, 2014