Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus (SoL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02290860|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : May 3, 2018
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 :||December 31, 2017|
|Estimated Study Completion Date :||December 2018|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|