- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01195142
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
Conditions
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
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Dublin, Ireland, 24
- Diabetes Day Centre, The Adelaide and Meath Hosptial
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Leinster
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Dublin, Leinster, Ireland, Dublin 4
- Nutrigenomics Group, University College Dublin
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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 |
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PCOS-CSAT
Women with PCOS
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Control-CSAT
Control population consisting of women without PCOS, matched for age and BMI with the PCOS cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDC-UCD-ATCS
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.
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