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

NCT ID: NCT02290860

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-12-31

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.

Conditions

Diabetes, Gestational

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention

Type 2 diabetes diagnosis test.

Group Type: OTHER

Type 2 diabetes diagnosis test

Intervention Type: PROCEDURE

Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Jean-Luc Ardilouze

Endocrinologist, researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Luc Ardilouze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

Centre de recherche clinique du CHUS

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

14-161

Identifier Type: -

Identifier Source: org_study_id