Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Official title:

Insulin Resistance in Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606671
• Other study ID #: PCOS
• Status: Completed
• Phase: N/A
• First received: January 17, 2008
• Last updated: February 1, 2008
• Start date: February 2004
• Est. completion date: May 2006

Study information

• Verified date: January 2008
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Denmark	Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre	Hvidovre

Sponsors (4)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Aage Bangs Fond, Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland., Diabetesforeningen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance		2004-2006	No
Secondary	gene expression of cytokines in fatty tissue		2004-2006	No