- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00647023
Incretin Secretion in Women With Polycystic Ovary Syndrome (PCOS)
March 26, 2008 updated by: Hvidovre University Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
|
1000 mg metformin x 2 daily during 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 26, 2008
First Posted (Estimate)
March 31, 2008
Study Record Updates
Last Update Posted (Estimate)
March 31, 2008
Last Update Submitted That Met QC Criteria
March 26, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Incretins and PCOS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.