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

Not Applicable

Completed

• Conditions: Diabetes, Gestational

• Registration Number: NCT02290860
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Study Start: 2014-12
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
abnormal glucose tolerance	8 weeks after delivery

Trial Locations

Locations (1)

Centre de recherche clinique du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada