Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 18
- 主要终点
- Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes
研究概览
简要总结
The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.
详细描述
Among the environmental factors leading to type 1 diabetes in childhood, the most important are certain viral infections and possibly some dietary factors. Among the latter cow's milk proteins are of special interest. They have been shown to be involved in the pancreatic beta-cell lesion in animal experiments. In humans there are some indications of a role of early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. The hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention trial should provide a definite answer.
This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the disease, by administering in infancy after breast feeding until the age of 6-8 months such a formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. The children in the control group, carrying a similar increased genetic risk, will receive a conventional cow's milk based formula .
This project is a pilot multicenter trial comprising 15 hospitals in Finland.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the participant must have a mother, biological father or sibling with type 1 diabetes
- •the participant must carry a susceptible HLA genotype(HLA-DQB1*02 and/or DQB1*0302 without protective alleles (DQB1*0301, *0602 and *0603)
排除标准
- •no telephone
- •no accessibility to any of the research centers
- •inability of parents to understand the study and instructions
- •unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
- •gestational age less than 36 weeks
- •Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
- •the newborn infant has received any cow's milk-based product prior to randomization
研究组 & 干预措施
A highly hydrolyzed casein formula
干预措施: A highly hydrolyzed formula (Dietary Supplement)
A conventiona cow's milk based formula
干预措施: A regular cow's milk based formula (Dietary Supplement)
结局指标
主要结局
Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes
时间窗: 10 years
次要结局
未报告次要终点
研究者
Mikael Knip
Professor of Pediatrics
University of Helsinki