Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00606671
First received: January 17, 2008
Last updated: February 1, 2008
Last verified: January 2008
  Purpose

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
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Insulin Resistance in Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: 2004-2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gene expression of cytokines in fatty tissue [ Time Frame: 2004-2006 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Fat and muscle biopsies


Enrollment: 65
Study Start Date: February 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

lean and obese women with and without PCOS

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606671

Locations
Denmark
Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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
  More Information

No publications provided

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
Study First Received: January 17, 2008
Last Updated: February 1, 2008
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 29, 2014