Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

NCT ID: NCT00606671

Last Updated: 2008-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

lean control women without PCOS

No interventions assigned to this group

2

lean women with PCOS

No interventions assigned to this group

3

Obese control women without PCOS

No interventions assigned to this group

4

Obese women with PCOS

No interventions assigned to this group

1xx - 04 LC

lean control women

No interventions assigned to this group

1xx-04 LP

lean women with PCOS

No interventions assigned to this group

1xx-04 OC

obese control women

No interventions assigned to this group

1xx-04 OP

obese women with PCOS

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diabetesforeningen

OTHER

Sponsor Role collaborator

Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland.

UNKNOWN

Sponsor Role collaborator

Aage Bangs Fond

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pernille Fog Svendsen, MD

Role: PRINCIPAL_INVESTIGATOR

Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre

Hvidovre, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PCOS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The PCOS Challenge Study
NCT05797909 RECRUITING