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Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00606671
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : February 4, 2008
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Polycystic Ovary Syndrome

Study Design

Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Insulin Resistance in Polycystic Ovary Syndrome (PCOS)
Study Start Date : February 2004
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

lean control women without PCOS
lean women with PCOS
Obese control women without PCOS
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

Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 2004-2006 ]

Secondary Outcome Measures :
  1. gene expression of cytokines in fatty tissue [ Time Frame: 2004-2006 ]

Biospecimen Retention:   Samples With DNA
Fat and muscle biopsies

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
lean and obese women with and without PCOS

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606671

Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland.
Aage Bangs Fond
Principal Investigator: Pernille Fog Svendsen, MD Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
More Information

Responsible Party: Lisbeth Nilas, Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT00606671     History of Changes
Other Study ID Numbers: PCOS
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: February 4, 2008
Last Verified: January 2008

Keywords provided by Hvidovre University Hospital:
polycystic ovary syndrome (PCOS)

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases