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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014