PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Body height
研究概览
简要总结
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. This treatment lowers undesirable events like macrosomia or premature birth. However, unitl gestational diabetes is diagnosed the fetus is exposed to increased intrauterine glucose levels. The long-term effects of a well-managed gestational diabetes on the development of the offspring is still not well understood. Therefore, the PREG - Offspring study investigates several aspects of development in children from healthy and gestational diabetes mothers until adulthood.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed informed consent provided by child and parent
- •documented oral glucose tolerance test of the mother during pregnancy
- •adequate management of gestational diabetes until birth
排除标准
- •severe malformation that makes an examination impossible
- •existent of coagulation disorder with increased risk of bleeding after blood sampling
结局指标
主要结局
Body height
时间窗: Change in body height from birth to age 6, 10, 14 and 17
Body height is measured with a tape measure in centimeter (cm)
次要结局
- Blood pressure(Change of blood pressure from age 6 to age 10, 14 and 17)
- Activity level(Change of activity level from age 6 to 10, 14 and 17)
- Body weight(Change in body weight from birth to age 6, 10, 14 and 17)
- Body fat(Change of body fat from age 6 to age 10, 14 and 17)
- Continuous glucose monitoring(Change of blood glucose from age 6 to age 10, 14 and 17)
- Pubertal development scale(Change of pubertal development scale from age 6 to age 10, 14 and 17)
- Blood glucose(Change of blood glucose from age 6 to age 10, 14 and 17)
- HbA1C(Change of HbA1C from age 6 to age 10, 14 and 17)
- Cardiometabolic risk markers(Change of cardiometabolic risk markers from age 6 to 10, 14 and 17)
- Magnetic resonance imaging(Change of magnetic resonance images from age 6 to 10, 14 and 17)