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临床试验/NCT03316261
NCT03316261招募中不适用

Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials

Helmholtz Zentrum München1 个研究点 分布在 1 个国家目标入组 1,000,000 人开始时间: 2017年10月19日最近更新:
适应症

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

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

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Anette-Gabriele Ziegler

Director - Institute of Diabetes Research

Helmholtz Zentrum München

研究点 (1)

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