Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- abnormal glucose tolerance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
研究组 & 干预措施
Intervention
Type 2 diabetes diagnosis test.
干预措施: Type 2 diabetes diagnosis test (Procedure)
结局指标
主要结局
abnormal glucose tolerance
时间窗: 8 weeks after delivery
次要结局
未报告次要终点
研究者
Jean-Luc Ardilouze
Endocrinologist, researcher
Université de Sherbrooke