NCT00606671

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
Last Updated

February 4, 2008

Status Verified

January 1, 2008

Enrollment Period

2.2 years

First QC Date

January 17, 2008

Last Update Submit

February 1, 2008

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome (PCOS)

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

    2004-2006

Secondary Outcomes (1)

  • gene expression of cytokines in fatty tissue

    2004-2006

Study Arms (8)

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 Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

lean and obese women with and without PCOS

You may qualify if:

  • 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

You may not qualify if:

  • BMI \> 40. mani fest diabetes or other known diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fat and muscle biopsies

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Pernille Fog Svendsen, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2008

First Posted

February 4, 2008

Study Start

February 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 4, 2008

Record last verified: 2008-01

Locations

DK(1)