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

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

      • Hvidovre, Denmark, 2650
        • Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre

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.

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

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.

Clinical Trials on Polycystic Ovary Syndrome

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