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

Sponsor
The Adelaide and Meath Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01195142
Collaborator
University College Dublin (Other)
10
Enrollment
2
Locations
7
Duration (Months)
5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Adipose Tissue Gene Expression Profiles in Women With PCOS Versus Controls Matched for BMI
    Study Start Date :
    Dec 1, 2007
    Actual Primary Completion Date :
    Jul 1, 2008
    Actual Study Completion Date :
    Jul 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    PCOS-CSAT

    Women with PCOS
    Control-CSAT

    Control population consisting of women without PCOS, matched for age and BMI with the PCOS cohort

    Outcome Measures

    Primary Outcome Measures

    1. Transcriptomic profiling of subcutaneous adipose tissue of women with PCOS and age and BMI matched controls [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.

    Secondary Outcome Measures

    1. Measurement of biomarkers of metabolic health (lipid, inflammatory markers) in plasma of PCOS cases and controls [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Nutrigenomics Group, University College Dublin Dublin Leinster Ireland Dublin 4
    2 Diabetes Day Centre, The Adelaide and Meath Hosptial Dublin Ireland 24

    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, Dr, University College Dublin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01195142
    Other Study ID Numbers:
    • DDC-UCD-ATCS
    First Posted:
    Sep 6, 2010
    Last Update Posted:
    Sep 6, 2010
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    PCOS
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Sep 6, 2010