Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)
CS
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
1 other identifier
observational
201
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 2, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedSeptember 6, 2010
July 1, 2008
1.7 years
September 2, 2010
September 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls
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
Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Secondary Outcomes (3)
Assessment of concentrations of androgens in women with PCOS compared with controls
Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Assessment of lipid profile in women with PCOS compared with age matched controls
Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Assessment of inflammatory profile in women with PCOS compared with controls
Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Study Arms (2)
PCOS cohort
Women with PCOS as diagnosed by the NIH criteria
Control cohort
Women without PCOS
Eligibility Criteria
Women with PCOS and a control population of women matched for age and body mass index (BMI) and insulin resistance
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Adelaide and Meath Hospitallead
- University College Dublincollaborator
Study Sites (2)
Diabetes Day Centre, The Adelaide and Meath Hosptial
Dublin, Leinster, Dublin 24, Ireland
Nutrigenomics Research Group, University College Dublin
Dublin, Leinster, Dublin 4, Ireland
Related Publications (2)
Gidwani S, Phelan N, McGill J, McGowan A, O'Connor A, Young IS, Gibney J, McEneny J. Polycystic ovary syndrome influences the level of serum amyloid A and activity of phospholipid transfer protein in HDL(2) and HDL(3). Hum Reprod. 2014 Jul;29(7):1518-25. doi: 10.1093/humrep/deu115. Epub 2014 May 19.
PMID: 24842896DERIVEDPhelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.
PMID: 21270384DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Gibney, Dr
The Adelaide and Meath Hospital
- PRINCIPAL INVESTIGATOR
Helen M Roche, Prof
University College Dublin
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2010
First Posted
September 6, 2010
Study Start
November 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
September 6, 2010
Record last verified: 2008-07