Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum? (DG4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00921882
First received: June 10, 2009
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.


Condition Intervention
Gestational Diabetes Mellitus
Type 2 Diabetes
Procedure: Oral glucose tolerance test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Oral glucose tolerance test [ Time Frame: 8 weeks post partum ] [ Designated as safety issue: No ]
    Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test


Secondary Outcome Measures:
  • Acceptability of screening test [ Time Frame: 8 weeks post partum ] [ Designated as safety issue: No ]
    Prefered moment to do the screening test (48 hours post partum or 8 weeks post partum)


Enrollment: 51
Study Start Date: June 2008
Study Completion Date: May 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral glucose tolerance test
oral glucose tolerance test performed 48 hours post-partum and 8 weeks post-partum.
Procedure: Oral glucose tolerance test
Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with gestational diabetes mellitus who delivered.

Criteria

Inclusion Criteria:

  • Dx of gestational diabetes treated with insulin
  • To be in post-partum
  • Delivery of a baby of at least 37 weeks of gestation
  • Have signed the consent form

Exclusion Criteria:

  • History of glucose intolerance of diabetes before the pregnancy
  • Obstetrical pathology during pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921882

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00921882     History of Changes
Other Study ID Numbers: 07-084
Study First Received: June 10, 2009
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Type 2 diabetes
Post-partum screening

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014