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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus (SoL)

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ClinicalTrials.gov Identifier: NCT02290860
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
University of Toronto
University of Manitoba
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

Brief Summary:

Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the diagnostic criteria used and the population being studied.

GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S recommendation has failed worldwide for the same reasons: the presently impractical pattern of the testing. A solution is direly needed.

Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically, to facilitate the recommended T2DM-pP-S in women diagnosed with GDM.

We hypothesize that, in GDM women, results of an OGTT performed after delivery, before hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks postpartum (OGTT-2). Our aims are:

  1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of OGTT-1 established by our Stage-1 study.
  2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the 2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2.
  3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks postpartum).

If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum OGTT will be avoided. Medical practice will change.


Condition or disease Intervention/treatment Phase
Diabetes, Gestational Procedure: Type 2 diabetes diagnosis test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 301 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial.
Study Start Date : December 2014
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Intervention
Type 2 diabetes diagnosis test.
Procedure: Type 2 diabetes diagnosis test
Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.



Primary Outcome Measures :
  1. abnormal glucose tolerance [ Time Frame: 8 weeks after delivery ]


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
Criteria

Inclusion Criteria:

  • Women aged between 18 and 45 years;
  • Having a positive diagnosis of gestational diabetes mellitus (GDM) (IADPSG or CDA criteria or patient followed for GDM);
  • Treated with diet, insulin or oral hypoglycemic agents;
  • Have given birth to a child at term (gestational age ≥ 37 weeks);
  • 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.).

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): NCT02290860


Locations
Canada, Quebec
Centre de recherche clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
University of Toronto
University of Manitoba
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02290860     History of Changes
Other Study ID Numbers: 14-161
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

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