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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01392781
• Other study ID #: 14/1-3-2011
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2011
• Last updated: July 12, 2011
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2011
• Source: Aristotle University Of Thessaloniki
• Contact: Georgios Daskalopoulos, M.D.
• Email: daskalog[@]gmail.com
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PCOS (criteria 2003)

• Healthy controls

Exclusion Criteria:

• any condition mimicking PCOS

• any systematic disease

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
Greece	Second Department of Obstetrics and Gynecology, Third Department of Cardiology, Second Propedeutic Department of Internal Medicine, Aristotle University	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes		1 hour	No
Primary	Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes		1 hour	No
Primary	Cardiovascular Risk Assessment and differences between the phenotypes		1 hour	No