NCT01115621Unknown不适用
BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
Institut fur Diabetesforschung, Munich, Germany2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2001年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Effect of dietary intervention on the development of islet autoantibodies
研究概览
简要总结
The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk
排除标准
- •If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes
结局指标
主要结局
Effect of dietary intervention on the development of islet autoantibodies
时间窗: 3 years
Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.
次要结局
- Effect of dietary intervention on the development of Type 1 diabetes.(10 years)
研究者
研究点 (2)
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