Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus (SoL)
|ClinicalTrials.gov Identifier: NCT02290860|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : May 9, 2017
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:
- To validate in Caucasian women the predictive threshold value of the 2hr-glucose of OGTT-1 established by our Stage-1 study.
- 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.
- 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)|
|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|
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.
- abnormal glucose tolerance [ Time Frame: 8 weeks after delivery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290860
|Centre de recherche clinique du CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Jean-Luc Ardilouze, MD, PhD||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|