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Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT00606671
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : February 4, 2008
Sponsor:
Collaborators:
Diabetesforeningen
Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland.
Aage Bangs Fond
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date January 17, 2008
First Posted Date February 4, 2008
Last Update Posted Date February 4, 2008
Study Start Date February 2004
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2008)		 insulin resistance [ Time Frame: 2004-2006 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 1, 2008)		 gene expression of cytokines in fatty tissue [ Time Frame: 2004-2006 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)
Official Title Insulin Resistance in Polycystic Ovary Syndrome (PCOS)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Fat and muscle biopsies
Sampling Method Non-Probability Sample
Study Population lean and obese women with and without PCOS
Condition Polycystic Ovary Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2008)		 65
Original Actual Enrollment Same as current
Actual Study Completion Date May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00606671
Other Study ID Numbers PCOS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lisbeth Nilas, Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
Study Sponsor Hvidovre University Hospital
Collaborators
  • Diabetesforeningen
  • Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland.
  • Aage Bangs Fond
Investigators
Principal Investigator: Pernille Fog Svendsen, MD Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
PRS Account Hvidovre University Hospital
Verification Date January 2008