Urine-plasminogen as a Predictor for Development Of Preeclampsia in Pregnant Women With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- preeclampsia
研究概览
简要总结
A tonic active epithelial Na+ channel (ENaC) in pre-eclampsia (PE) escaped normal hormonal control may offer an attractive explanatory model for the pathophysiology of established PE. The channel is activated by plasmin. Microalbuminuria predicts the development of pre-eclampsia in pregnant patients with pregestational diabetes type 1. The investigators hypothesize that urine-plasmin excreted in the kidneys, when proteinuria occurs, could be the cause. The investigators want to test the correlation between measurable plasmin/plasminogen in the urine early in pregnancy and the development of preeclampsia in pregnant patients with type 1 diabetes.
详细描述
Study aim and hypothesis:
Aim:
To test whether there is a measurable correlation between plasmin/plasminogen, abnormally excreted in the kidneys, and the development of pre-eclampsia in pregnant women with Type 1 diabetes.
Hypothesis:
- The amount of proteases ( plasmin/plasminogen ), excreted in urine, predicts development of preeclampsia in pregnant patients with type 1 diabetes.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton gravida,
- •over 18 years,
- •Pregestational type 1 diabetes. Gestation week 8-14.
排除标准
- •Possible comorbidity like systemic lupus erythematosus (SLE), hypertension and rheumatoid arthritis.
- •Organic or systematic diseases with clinical relevance ( ex. Malignity)
- •However it has to be mentioned that quite some patients have thyroid diseases with no impact on the kidneys nor hypertension. It is therefore possible to include these patients.
- •Thyroid diseases are NOT a reason for exclusion.
结局指标
主要结局
preeclampsia
时间窗: 3 years
The development of preeclampsia, defined by hypertension ( \> 140/90 mmHg) and proteinuria ( \>0,3 g/24 hour).
次要结局
- preterm delivery(3 years)
- light for gestational age(3 years)
研究者
Lise Hald Nielsen
doctor, Ph.D student
Odense University Hospital