Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes
研究概览
简要总结
The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.
详细描述
Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Day 至 6 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: up to age 6 weeks
- •provided written informed consent by custodial parent
排除标准
- 未提供
结局指标
主要结局
greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes
时间窗: one-time testing before age 6 weeks
increased risk will be identified by risk scores derived from SNPs
次要结局
未报告次要终点
研究者
Anette-Gabriele Ziegler
Director - Institute of Diabetes Research
Helmholtz Zentrum München
