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

Diabetes, Gestational Clinical Trial

— SoL  

Official title:

Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290860
• Other study ID #: 14-161
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre de recherche clinique du CHUS	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	University of Manitoba, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abnormal glucose tolerance		8 weeks after delivery