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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Aristotle University Of Thessaloniki.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01392781
First received: July 6, 2011
Last updated: July 12, 2011
Last verified: July 2011

July 6, 2011
July 12, 2011
April 2011
October 2011   (final data collection date for primary outcome measure)
  • high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Cardiovascular Risk Assessment and differences between the phenotypes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01392781 on ClinicalTrials.gov Archive Site
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Markers and Calculation of Cardiovascular Risk in the Distinct Phenotypes of Polycystic Ovary Syndrome
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

blood serum

Non-Probability Sample

Outpatient women with PCOS (normalweight, overweight plus obese) Healthy volunteers controls (normalweight, overweight plus obese)

Polycystic Ovary Syndrome
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  • normoweight PCOS patients
  • normoweight controls
  • overweight plus obese PCOS patients
  • overwqeight plus obese controls
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
January 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of PCOS (criteria 2003)
  • Healthy controls

Exclusion Criteria:

  • any condition mimicking PCOS
  • any systematic disease
Female
15 Years to 35 Years
Yes
Contact: Georgios Daskalopoulos, M.D. daskalog@gmail.com
Greece
 
NCT01392781
14/1-3-2011
Yes
Daskalopoulos Georgios, Aristotle University of Thessaloniki
Aristotle University Of Thessaloniki
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Aristotle University Of Thessaloniki
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP