Postpartum Screening of Type 2 Diabetes (Tot ou tard)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Université de Sherbrooke
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01869608
First received: May 15, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).

However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking… A mother-friendly solution is direly needed.

The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.

The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.


Condition Intervention
Type 2 Diabetes
Procedure: oral glucose tolerance test 2 days post-partum

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Diagnosis of abnormal glucose tolerance [ Time Frame: 12 weeks postpartum ] [ Designated as safety issue: No ]
    Oral glucose tolerance test


Secondary Outcome Measures:
  • Patient's satisfaction [ Time Frame: 12 weeks post-partum ] [ Designated as safety issue: No ]
    Satisfaction questionnaire


Estimated Enrollment: 145
Study Start Date: April 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: postpartum screening
Oral glucose tolerance test 2 days post-partum
Procedure: oral glucose tolerance test 2 days post-partum
Screening for type 2 diabetes after gestational diabetes mellitus.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged between 18 and 45 years;
  • Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
  • Treated with diet or insulin;
  • Have given birth to a child at term; gestational age > 37 weeks;
  • Have been followed during her pregnancy by a physician who delivers in CHUS;
  • Have signed the consent form.

Exclusion Criteria:

  • History of glucose intolerance or diabetes before the pregnancy;
  • Have presented another obstetrical pathology during the pregnancy;

    • Severe gestational high blood pressure with proteinuria;
    • Delayed intrauterine development syndrome;
    • Pregnancy with more than a foetus;
    • Drug addiction;
    • Had complications during the delivery such as:
  • Moderate to severe postpartum bleeding;
  • Surgery in postpartum (curettage, hysterectomy, etc.).
  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: NCT01869608

Contacts
Contact: Jean-Luc Ardilouze, MD, PhD 819-346-1110 ext 15241 Jean-Luc.Ardilouze@USherbrooke.ca
Contact: Julie Ménard, PhD 819-346-1110 ext 13534 jumenard.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Jean-Luc Ardilouze, MD, PhD    819-346-1110 ext 15241    Jean-Luc.Ardilouze@USherbrooke.ca   
Contact: Julie Ménard, PhD    819-346-1110 ext 13534    jumenard.chus@ssss.gouv.qc.ca   
Principal Investigator: Jean-Luc Ardilouze, MD, PhD         
Sponsors and Collaborators
Université de Sherbrooke
The Lawson Foundation
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
  More Information

No publications provided

Responsible Party: Jean-Luc Ardilouze, Full professor, endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01869608     History of Changes
Other Study ID Numbers: 13-005
Study First Received: May 15, 2013
Last Updated: April 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
postpartum screening
type 2 diabetes

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 July 20, 2014