Markers and Calculation of Cardiovascular Risk in the Distinct Phenotypes of Polycystic Ovary Syndrome

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT01392781
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. According to the revised criteria of 2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence supporting the existence of different levels of cardiometabolic risk between the four phenotypic groups of the syndrome. The purpose of this study is to determine the cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the four phenotypes of the syndrome as well as the levels of low inflammation serum markers and the possible correlations of the between the outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Status Verified: 2011-07
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Posted: 2011-07-13
• Primary Completion: 2011-10
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Diagnosis of PCOS (criteria 2003)
• Healthy controls

Exclusion Criteria

• any condition mimicking PCOS
• any systematic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes	1 hour
Cardiovascular Risk Assessment and differences between the phenotypes	1 hour
Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes	1 hour

Trial Locations

Locations (1)

Second Department of Obstetrics and Gynecology, Third Department of Cardiology, Second Propedeutic Department of Internal Medicine, Aristotle University; 🇬🇷 Thessaloniki, Greece