Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

Verified by: Hvidovre University Hospital, January 2008
First Received: January 17, 2008 | Last Updated: February 1, 2008 | Phase: N/A | Start Date: February 2004
Overall Status: Completed | Estimated Enrollment: 65
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The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We...

Brief Summary

Official Title: “Insulin Resistance in Polycystic Ovary Syndrome (PCOS)”

The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1.

These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.

  • Study Type: Observational
  • Study Design: Observational Model: Case Control, Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2006

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • lean control women without PCOS
  • : 2
    • lean women with PCOS
  • : 3
    • Obese control women without PCOS
  • : 4
    • Obese women with PCOS
  • : 1xx - 04 LC
    • lean control women
  • : 1xx-04 LP
    • lean women with PCOS
  • : 1xx-04 OC
    • obese control women
  • : 1xx-04 OP
    • obese women with PCOS

Outcome Measures for this Clinical Trial

Primary Measures

  • insulin resistance
    • Time Frame: 2004-2006
      Safety Issue?: No

Secondary Measures

  • gene expression of cytokines in fatty tissue
    • Time Frame: 2004-2006
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Premenopausal women that meet the Rotterdam criteria for PCOS (BMI < 40)
  • Age and BMI matched control women that do not have any signs or symptoms of PCOS

Exclusion Criteria:

  • BMI > 40. mani fest diabetes or other known diseases

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 38 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Hvidovre University Hospital Other

Overall Clinical Trial Officials and Contacts

Pernille Fog Svendsen, MD Principal Investigator Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00606671

Study ID Number: PCOS

ClinicalTrials.gov Identifier: NCT00606671

Health Authority: Denmark: Danish Dataprotection Agency

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