Clinical trial NCT01195168: Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: The Adelaide and Meath Hospital
Sponsor class: OTHER
Collaborators: name: University College Dublin
First posted: 2010-09-06
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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


Eligibility 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

Primary outcomes:
measure: Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls
timeFrame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Secondary outcomes:
measure: Assessment of concentrations of androgens in women with PCOS compared with controls
timeFrame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
measure: Assessment of lipid profile in women with PCOS compared with age matched controls
timeFrame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
measure: Assessment of inflammatory profile in women with PCOS compared with controls
timeFrame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Diabetes Day Centre, The Adelaide and Meath Hosptial
state: Leinster
city: Dublin
country: Ireland
facility: Nutrigenomics Research Group, University College Dublin
state: Leinster
Study officials:
affiliation: The Adelaide and Meath Hospital
name: James Gibney, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Helen M Roche, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Phelan 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.