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Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS) (CS)

This study has been completed.
Sponsor:
Collaborator:
University College Dublin
Information provided by:
The Adelaide and Meath Hospital
ClinicalTrials.gov Identifier:
NCT01195168
First received: September 2, 2010
Last updated: September 3, 2010
Last verified: July 2008
History of Changes
  Purpose

Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Adelaide and Meath Hospital:

Primary Outcome Measures:
  • Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls [ Time Frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion ] [ Designated as safety issue: No ]
    Subjects underwent a standard 75g oral glucose tolerance test (OGTT) and blood were taken fasting and at 2 hours. Surrogate markers of insulin resistance (HOMA) and insulin sensitivity (Avignon index of Insulin Sensitivity; QUICKI) were calculated


Secondary Outcome Measures:
  • Assessment of concentrations of androgens in women with PCOS compared with controls [ Time Frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion ] [ Designated as safety issue: No ]
    Bloods were taken in the fasted state and circulating concentrations of androgens (DHEAS, testosterone, androstenedione) were assessed

  • Assessment of lipid profile in women with PCOS compared with age matched controls [ Time Frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion ] [ Designated as safety issue: No ]
    Bloods were taken in the fasted state and circulating concentrations of lipids assessed

  • Assessment of inflammatory profile in women with PCOS compared with controls [ Time Frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion ] [ Designated as safety issue: No ]
    Bloods were taken in the fasted state and circulating concetrations of several important markers of inflammation as well as key adipokines were assessed


Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 201
Study Start Date: November 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCOS cohort
Women with PCOS as diagnosed by the NIH criteria
Control cohort
Women without PCOS

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with PCOS and a control population of women matched for age and body mass index (BMI) and insulin resistance

Criteria

Inclusion Criteria:

  • Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
  • Were between the ages of 18 and 40

Exclusion Criteria:

  • Were under 18 years or greater than 40 years old,
  • Were non-Caucasian
  • Were pregnant, lactating or trying to conceive
  • Had a body mass index (BMI) <18kg/m2 or >50kg/m2
  • Had a recent illness or any chronic illness likely to influence results
  • Were taking hormonal contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195168

Locations
Ireland
Diabetes Day Centre, The Adelaide and Meath Hosptial
Dublin, Leinster, Ireland, Dublin 24
Nutrigenomics Research Group, University College Dublin
Dublin, Leinster, Ireland, Dublin 4
Sponsors and Collaborators
The Adelaide and Meath Hospital
University College Dublin
Investigators
Principal Investigator: James Gibney, Dr The Adelaide and Meath Hospital
Principal Investigator: Helen M Roche, Prof University College Dublin
  More Information

No publications provided by The Adelaide and Meath Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr James Gibney, The Adelaide and Meath Hospital Incorporating the National Children's Hospital
ClinicalTrials.gov Identifier: NCT01195168     History of Changes
Other Study ID Numbers: DDC-UCD-CS
Study First Received: September 2, 2010
Last Updated: September 3, 2010
Health Authority: Ireland: Research Ethics Committee

Keywords provided by The Adelaide and Meath Hospital:
PCOS

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

ClinicalTrials.gov processed this record on June 18, 2013