- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606671
Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)
February 1, 2008 updated by: Hvidovre University Hospital
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
65
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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Hvidovre, Denmark, 2650
- Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
-
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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 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
lean and obese women with and without PCOS
Description
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
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
insulin resistance
Time Frame: 2004-2006
|
2004-2006
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gene expression of cytokines in fatty tissue
Time Frame: 2004-2006
|
2004-2006
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pernille Fog Svendsen, MD, Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre
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
February 1, 2004
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
January 17, 2008
First Submitted That Met QC Criteria
February 1, 2008
First Posted (Estimate)
February 4, 2008
Study Record Updates
Last Update Posted (Estimate)
February 4, 2008
Last Update Submitted That Met QC Criteria
February 1, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCOS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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