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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
metformin 1500 mg
myoinositol 1500 mg
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, myoinositol, metformin, glucose-insulinemic metabolism, menstrual pattern, insulin-lowering therapies

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

myo-inositol

metformin

Arm Description

1500 mg/day myoinositol

1500 mg/day of metformin

Outcomes

Primary Outcome Measures

number of cycles

Secondary Outcome Measures

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).

Full Information

First Posted
March 12, 2012
Last Updated
July 22, 2020
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01791647
Brief Title
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, myoinositol, metformin, glucose-insulinemic metabolism, menstrual pattern, insulin-lowering therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myo-inositol
Arm Type
Active Comparator
Arm Description
1500 mg/day myoinositol
Arm Title
metformin
Arm Type
Active Comparator
Arm Description
1500 mg/day of metformin
Intervention Type
Drug
Intervention Name(s)
metformin 1500 mg
Intervention Type
Drug
Intervention Name(s)
myoinositol 1500 mg
Primary Outcome Measure Information:
Title
number of cycles
Time Frame
six months
Secondary Outcome Measure Information:
Title
effects of two therapies on glyco-insulinemic metabolism
Description
Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min).
Time Frame
six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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