The Belgian Diabetes in Pregnancy Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 5
- 主要终点
- BMI in offspring
研究概览
简要总结
Gestational diabetes (GDM) is a form of diabetes that develops during pregnancy. GDM is associated with increased risks for pregnancy complications such as macrosomia s and preterm delivery. Women with a history of GDM have a high risk to develop a type 2 diabetes (T2DM) within the next ten years after delivery. The children are also at increased risk of developing obesity and T2DM later in life. Studies are needed to find more accurate predictors for the metabolic risk later in life. This will help to individualize the follow-up and to develop tailored prevention strategies in women and offspring with a history of GDM. In this research project we will therefore investigate how the long-term metabolic risk can more accurately be predicted in a follow-up cohort of the 'Belgian Diabetes in Pregnancy study' (BEDIP-N). We will study the relationship between maternal weight, degree of body fat and degree of hyperglycaemia in pregnancy on the long-term metabolic risk of 375 women and offspring pairs 3-7 years after the delivery across different gestational glucose tolerance groups based on the 2013 WHO criteria in pregnancy. In addition, we will study whether a promising new biomarker, glycated CD59, is a good predictor for the long-term metabolic risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mothers who participated in the completed BEDIP-N study and received both the GCT as the OGTT during pregnancy
- •Offspring born at the time of participation in the BEDIP-N study
排除标准
- •Current pregnancy
- •Treatment that influences glycaemic status such as high dose corticoids.
- •History of bariatric surgery
- •gastro-intestinal surgery changing the absorption of glucose (Billroth II)
- •A normal study visit will not be possible (incompliance, psychiatric problems...)
- •Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes
- •Treatment that influences glycaemic status such as high dose corticoids.
- •A normal study visit will not be possible (incompliance, psychiatric problems...)
- •Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes
结局指标
主要结局
BMI in offspring
时间窗: 3-7 years after delivery
BMI z score as a continuous variable
A disorder of glucose metabolism in mothers
时间窗: 3-7 years after delivery
T2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria
次要结局
- Insulin sensitivity mothers HOMA(3-7 years after delivery)
- Insulin sensitivity mothers Matsuda(3-7 years after delivery)
- BMI in mothers(3-7 years after delivery)
- metabolic syndrome in mothers(3-7 years after delivery)
- Adiposity offsping skin folds(3-7 years after delivery)
- Beta-cell function mothers ISSI-2(3-7 years after delivery)
- Beta-cell function mothers Stumvoll(3-7 years after delivery)
- Adiposity mothers BIA(3-7 years after delivery)
- Adiposity mothers skin folds(3-7 years after delivery)
- overweight offspring(3-7 years after delivery)
- A disorder of glucose metabolism in offspring(3-7 years after delivery)
- insulin sensitivity offspring(3-7 years after delivery)
- Beta-cell function offsping(3-7 years after delivery)
- Beta-cell function mothers HOMA-B(3-7 years after delivery)
- metabolic syndrome in offsping(3-7 years after delivery)
- obesity offspring(3-7 years after delivery)
- Adiposity offsping BIA(3-7 years after delivery)