ISRCTN76104595已完成未知
Primary intervention with mucosal insulin for prevention of type one diabetes in infants at high genetic risk to develop diabetes
Medical Faculty Carl Gustav Carus (Germany)0 个研究点目标入组 25 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 09/07/2013:
- •1. Children aged 2 to 7 years who:
- •1.1. Have a multiplex first degree family history of T1DM (both parents, parent and siblings, or two siblings) and a type 1 diabetes susceptible Human Leukocyte Antigen (HLA) DR4-DQB1*0302 or DR4-DQB1*0304 haplotype and none of the following HLA DR or DQB1 alleles:
- •1.1.1 DR 11
- •1.1.2 DR 12
- •1.1.3 DQB1*0602
- •1.1.4 DR7-DQB1*0303
- •1.1.5 DR14-DQB1*0503
- •1.2. Have a sibling with T1DM and are identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling
- •2. Islet auto-antibody (IA-2) negative at time of recruitment
- •Previous inclusion criteria:
- •1. Children aged 2 to 7 years who:
- •1.1. Have a multiplex first degree family history of T1DM (both parents, parent and siblings, or two siblings) and have one of the following Human Leukocyte Antigen (HLA) genotypes:
- •1.1.1. DR4- DQA1*0301-DQB1*0302 / DR3- DQA1*0501-DQB1*0201
- •1.1.2. DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0302
- •1.1.3. DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0201
- •1.1.4. DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0304, or
- •1.2. Have a sibling with T1DM and are identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling
- •2. Islet auto-antibody (IA-2) negative at time of recruitment
排除标准
- •1. Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives
- •2. Prior or current participation in another intervention trial
研究者
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