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

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ClinicalTrials.gov Identifier: NCT00921882
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Gestational Diabetes Mellitus Type 2 Diabetes Procedure: Oral glucose tolerance test

Study Design

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?
Study Start Date : June 2008
Primary Completion Date : October 2012
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
Drug Information available for: Dextrose
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Oral glucose tolerance test [ Time Frame: 8 weeks post partum ]
    Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test


Secondary Outcome Measures :
  1. Acceptability of screening test [ Time Frame: 8 weeks post partum ]
    Prefered moment to do the screening test (48 hours post partum or 8 weeks post partum)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00921882     History of Changes
Other Study ID Numbers: 07-084
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by Jean-Luc Ardilouze, 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