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
  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 ] [ 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 ]

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

Ages Eligible for Study:   15 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Daskalopoulos Georgios, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01392781     History of Changes
Other Study ID Numbers: 14/1-3-2011
Study First Received: July 6, 2011
Last Updated: July 12, 2011
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014