The effect of metformin and myoinositol in women with polycystic ovary syndrome: role of body mass and adiponecti

Not Applicable

Completed

• Conditions: Polycystic ovary syndrome; Nutritional, Metabolic, Endocrine; Polycystic ovarian syndrome

• Registration Number: ISRCTN13199265
• Lead Sponsor: niversity clinical center of Republika Srpska

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34665453/ (added 20/10/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-05
• Study Start: 2021-04-14
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1. Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
2. Age 18 - 40 years

Exclusion Criteria

1. Significant liver or renal impairment
2. Other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
3. History of drug and alcohol abuse
4. History of breast and uterine cancer
5. Diagnosis of diabetes mellitus
6. Use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adiponectin measured using blood test at baseline and six months (after 12 hours of fasting)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Body mass index (kg/m²) and body composition changes measured by bioelectrical impedance at baseline and six months<br> 2. Testosterone level measured using blood test at baseline and six months (after 12 hours of fasting)<br> 3. Glyco-insulinemic metabolism measured using area under the curve insulin post oral glucose tolerance test (AUC insulin), area under the curve glucose post oral glucose tolerance test (AUC glucose), quantitative insulin sensitivity check index QUICKI and homeostasis model assessment index HOMA IR at baseline and six months (after 12 hours of fasting)<br> 4. Improvement/deterioration of clinical symptoms: hyperandrogenic features measured by Ferriman Gallwey score at baseline and six months<br>