NCT00647023

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

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
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
Last Updated

March 31, 2008

Status Verified

March 1, 2008

Enrollment Period

2.2 years

First QC Date

March 26, 2008

Last Update Submit

March 26, 2008

Conditions

Polycystic Ovary Syndrome

Study Arms (1)

A

EXPERIMENTAL
Drug: metformin

Interventions

metforminDRUG

1000 mg metformin x 2 daily during 8 months

A

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who fulfill the Rotterdam criteria for PCOS. Age 18-38

You may not qualify if:

  • Other endocrine diseases or diseases known to influence glucose/insulin/fat metabolism
  • Oral contraceptive administration within three months of study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Purpose
BASIC SCIENCE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

February 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 31, 2008

Record last verified: 2008-03