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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01392781
First Posted: July 13, 2011
Last Update Posted: July 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aristotle University Of Thessaloniki
  Purpose
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.

Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes [ Time Frame: 1 hour ]
  • Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes [ Time Frame: 1 hour ]
  • Cardiovascular Risk Assessment and differences between the phenotypes [ Time Frame: 1 hour ]

Biospecimen Retention:   Samples Without DNA
blood serum

Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
normoweight PCOS patients
normoweight controls
overweight plus obese PCOS patients
overwqeight plus obese controls

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient women with PCOS (normalweight, overweight plus obese) Healthy volunteers controls (normalweight, overweight plus obese)
Criteria

Inclusion Criteria:

  • Diagnosis of PCOS (criteria 2003)
  • Healthy controls

Exclusion Criteria:

  • any condition mimicking PCOS
  • any systematic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392781


Contacts
Contact: Georgios Daskalopoulos, M.D. daskalog@gmail.com

Locations
Greece
Second Department of Obstetrics and Gynecology, Third Department of Cardiology, Second Propedeutic Department of Internal Medicine, Aristotle University Recruiting
Thessaloniki, Greece
Contact: Vasileios Athyros, Prof         
Principal Investigator: Georgios Daskalopoulos         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daskalopoulos Georgios, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01392781     History of Changes
Other Study ID Numbers: 14/1-3-2011
First Submitted: July 6, 2011
First Posted: July 13, 2011
Last Update Posted: July 13, 2011
Last Verified: July 2011

Keywords provided by Aristotle University Of Thessaloniki:
PCOS
hsC-RP
Lp-PLA2
cardiovascular risk

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases


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