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

NCT ID: NCT01392781

Last Updated: 2011-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-01-31

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

normoweight PCOS patients

No interventions assigned to this group

normoweight controls

No interventions assigned to this group

overweight plus obese PCOS patients

No interventions assigned to this group

overwqeight plus obese controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of PCOS (criteria 2003)
• Healthy controls

Exclusion Criteria

• any condition mimicking PCOS
• any systematic disease

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Aristotle University of Thessaloniki

Locations

Second Department of Obstetrics and Gynecology, Third Department of Cardiology, Second Propedeutic Department of Internal Medicine, Aristotle University

Thessaloniki, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Georgios Daskalopoulos, M.D.

Role: CONTACT

daskalog@gmail.com

Facility Contacts

Vasileios Athyros, Prof

Role: primary

References

Daskalopoulos G, Karkanaki A, Piouka A, Prapas N, Panidis D, Gkeleris P, Athyros VG. Excess Metabolic and Cardiovascular Risk is not Manifested in all Phenotypes of Polycystic Ovary Syndrome: Implications for Diagnosis and Treatment. Curr Vasc Pharmacol. 2015;13(6):788-800. doi: 10.2174/1567201812666150120163025.

Reference Type: DERIVED

PMID: 25600030 (View on PubMed)

Other Identifiers

14/1-3-2011

Identifier Type: -

Identifier Source: org_study_id