TRIGR - Trial to Reduce IDDM in the Genetically at Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,156
- 试验地点
- 36
- 主要终点
- Number of Participants With Type 1 Diabetes Mellitus
研究概览
简要总结
The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The TRIGR study was targeted at newborns who are at genetic risk for type 1 diabetes because their mother, father and/or full sibling has type 1 diabetes. All families were encouraged to breast feed their infants for as long as possible. Prior to birth, the child was randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study determined whether weaning to a possibly protective infant formula decreases these children's chances of developing diabetes - as it does in the animal models for diabetes.
详细描述
The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes in subjects with risk-associated HLA genotypes and a first degree relative with type 1 diabetes, as it does in all relevant animal models for the disease.
Specific Aims:
I.a: To determine if weaning to a casein hydrolysate infant formula reduces the frequency of diabetes-predictive auto-antibodies in subjects with risk-associated HLA genotype and a first degree relative with type 1 diabetes (mother, father and/or full sibling).
I-b: To determine if weaning to a casein hydrolysate infant formula reduces the frequency of clinical diabetes in subjects with risk-associated HLA genotype and an affected first degree relative.
A secondary aim is to determine relationships between cow's milk antibodies, a measure of cow's milk exposure, and diabetes-associated auto-antibodies.
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
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biological parent and/or full (not half) sibling of the newborn infant had type 1 diabetes as defined by the World Health Organization
- •The infant's parent or legal guardians gave signed consent to participate
排除标准
- •An older sibling of the newborn infant had been included in the TRIGR intervention
- •Multiple gestation
- •The parents were unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
- •The newborn infant had a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
- •The gestational age of the newborn infant was less than 35 weeks.
- •The infant was older than 7 days at randomization.
- •Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centers, the family has no telephone).
- •The infant had received any infant formula other than Nutramigen prior to randomization.
- •No HLA sample drawn before the age of 8 days.
结局指标
主要结局
Number of Participants With Type 1 Diabetes Mellitus
时间窗: 12 and 18 months and annually from 2 years up to 14 years
Number of participants with Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age and in the final year of the study.
次要结局
- Number of Participants With Diabetes Associated Autoantibodies(3, 6, 9, 12, 18 months and annually from 2 years up to 14 years)
研究者
Mikael Knip
Professor, Principal Investigator
University of Helsinki