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Incretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00647023
Collaborator
University of Copenhagen (Other)
66
Enrollment
1
Arm
26.9
Duration (Months)

Study Details

Study Description

Brief Summary

The incretin hormones are secreted from the gastrointestinal tract in response to nutrient ingestion, and are responsible for 70 % of insulin secretion in response to glucose. The incretin response is attenuated in subjects with type 2 diabetes and other conditions associated with insulin resistance. Polycystic ovary syndrome (PCOS) is characterised by irregular periods and increased androgen levels. It is the most common endocrine disorder amongst young women at fertile age, and the most common cause of female infertility. Insulin resistance plays an important role in the development of the disease, and women with PCOS are at increased risk of developing tyoe 2 diabetes. the incretin hormones have not previously been investigated in women with PCOS, and the purpose of the present study was to investigate the secretion of the two most important incretin hormones Glucose-like peptide-1 (GLP-1) and Glucose dependent insulinotropic peptide (GIP) during a three hour oral glucose tolerance test.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Primary Purpose:
Basic Science
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
May 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: metformin
1000 mg metformin x 2 daily during 8 months

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Subjects who fulfill the Rotterdam criteria for PCOS. Age 18-38
    Exclusion Criteria:

    • Other endocrine diseases or diseases known to influence glucose/insulin/fat metabolism

    • Oral contraceptive administration within three months of study start

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hvidovre University Hospital
    • University of Copenhagen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00647023
    Other Study ID Numbers:
    • Incretins and PCOS
    First Posted:
    Mar 31, 2008
    Last Update Posted:
    Mar 31, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Metformin

    Study Results

    No Results Posted as of Mar 31, 2008