Diabetes, Gestational Clinical Trial
Official title:
Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial.
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.
n/a
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