Clinical trial NCT01195142: Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls
Official title: Adipose Tissue Gene Expression Profiles in Women With PCOS Versus Controls Matched for BMI
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: 10
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)

Brief summary: Adipose tissue is a central organ in mediating metabolic health. There is some evidence that women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. The aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with a control population matched on the basis of age and body mass index (BMI). A secondary aim was to then relate these gene expression profiles to the biochemical environment.

Detailed description: Adipose tissue is a central organ in mediating metabolic health. There is some evidence that women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. The aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with a control population matched on the basis of age and body mass index (BMI). A secondary aim was to then relate these gene expression profiles to the biochemical environment.

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: Transcriptomic profiling of subcutaneous adipose tissue of women with PCOS and age and BMI matched controls
timeFrame: Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion
Secondary outcomes:
measure: Measurement of biomarkers of metabolic health (lipid, inflammatory markers) in plasma of PCOS cases and controls
timeFrame: Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Nutrigenomics Group, University College Dublin
state: Leinster
city: Dublin
country: Ireland
facility: Diabetes Day Centre, The Adelaide and Meath Hosptial
Study officials:
affiliation: The Adelaide and Meath Hospital
name: James Gibney, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Helen M Roche, Dr
role: PRINCIPAL_INVESTIGATOR
References: