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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791647
• Other study ID #: 000102011
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• metformin 1500 mg

• myoinositol 1500 mg

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cycles		six months
Secondary	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