Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls

September 3, 2010 updated by: The Adelaide and Meath Hospital

Adipose Tissue Gene Expression Profiles in Women With PCOS Versus Controls Matched for BMI

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dublin, Ireland, 24
        • Diabetes Day Centre, The Adelaide and Meath Hosptial
    • Leinster
      • Dublin, Leinster, Ireland, Dublin 4
        • Nutrigenomics Group, University College Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PCOS-CSAT
Women with PCOS
Control-CSAT
Control population consisting of women without PCOS, matched for age and BMI with the PCOS cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptomic profiling of subcutaneous adipose tissue of women with PCOS and age and BMI matched controls
Time Frame: Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion
Gene expression profiles from women with PCOS and controls matched for age and BMI were determined by microarray analysis of whole subcutaneous adipose tissue samples. Single gene changes as well as pathway analyses will be used to determine differently expressed genes and pathways between the PCOS cohort and controls.
Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of biomarkers of metabolic health (lipid, inflammatory markers) in plasma of PCOS cases and controls
Time Frame: Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion
Biomarkers of metabolic health were assessed in plasma of women with PCOS and age and BMI matched controls. Lipid profile, hormonal profile, various key inflammatory markers and adipokines will be measured. Glucose and insulin concentrations will be assessed also. All parameters will be assessed following a 12 hour over night fast at the study location.
Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helen M Roche, Dr, University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

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