Back to resultsIncretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovary Syndrome
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
metformin
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00647023
First Posted
March 26, 2008
Last Updated
March 26, 2008
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00647023
Brief Title
Incretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
1000 mg metformin x 2 daily during 8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Incretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)
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