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

May 2, 2018 updated by: Jean-Luc Ardilouze, Université de Sherbrooke

Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with gestational diabetes mellitus who delivered.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral glucose tolerance test
Time Frame: 8 weeks post partum
Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test
8 weeks post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

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 (Actual)

June 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-084

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.

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