Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in insulin sensitivity
研究概览
简要总结
Aim of the study:
To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.
Method:
Botnia clamp in women before, immediately after delivery and 6 months post partum. The investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. In addition the investigators will collect feces samples from the mother and baby in order to determine microbiota.
Perspectives:
Diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written consent before study start.
- •Pregnant.
- •GDM for the GDM group.
- •No diabetes for the control group.
排除标准
- •Women with multiple pregnancy.
- •New pregnancy before all three examinations has been done.
- •Severe, debilitating, concurrent diseases.
- •Serious or intolerable adverse reactions associated with the studies.
结局指标
主要结局
Change in insulin sensitivity
时间窗: Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.
Performing a Botnia clamp 3 times around parturition on women with GDM and comparing them with women with no GDM. The women will be their own control prospectively but also compared with a control group without gestational diabetes in order to compared them cross sectionally
次要结局
- Changes in the microbiota(Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.)