Hospital for Children and Adolescents, University of Helsinki, Biomedicum Helsinki 2 U, PO Box 20, 00014, Helsinki, Finland.
Diabetologia. 2011 Mar;54(3):627-33. doi: 10.1007/s00125-010-1964-9. Epub 2010 Dec 12.
AIMS/HYPOTHESIS: The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes.
The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria. The study is being performed in 15 countries in three continents. First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics, diabetes registries, and from other endocrinology or obstetrics offices and websites. HLA typing was performed at birth from cord or heel stick blood, and the results sent to the study's Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre. All mothers recruited were encouraged to breastfeed. The intervention lasted for 6 to 8 months, and weaning formulas based on hydrolysed casein and standard cow's milk were compared.
TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032. Of those enrolled, 80% were exposed to the study formula. The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%. The randomisation code will be opened when the last recruited child turns 10 years of age, i.e. in 2017.
CONCLUSIONS/INTERPRETATION: The TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study. TRIGR is the first ever primary prevention trial for type 1 diabetes and, if completed successfully, will provide a definite answer to the research question.
ClinicalTrials.gov NCT00179777
The study was funded by the National Institute of Child Health and Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) (grant numbers HD040364, HD042444 and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International and the Commission of the European Communities (specific RTD programme 'Quality of Life and Management of Living Resources', contract number QLK1-2002-00372 'Diabetes Prevention'. Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation).
目的/假设：TRIGR 研究旨在确定在婴儿期用高度水解配方代替母乳喂养是否会降低 1 型糖尿病的风险。
研究人群包括一级亲属患有 1 型糖尿病且符合增加的 HLA 纳入标准但不符合排除标准的新生儿。该研究正在三大洲的 15 个国家进行。1 型糖尿病患者的一级亲属从糖尿病诊所、糖尿病登记处以及其他内分泌或妇产科办公室和网站中确定。出生时从脐带或足跟采血进行 HLA 分型，并在 2 周内将结果发送至研究的数据管理单位，以将合格情况通知临床研究中心。所有招募的母亲都被鼓励母乳喂养。干预持续 6 至 8 个月，比较基于水解酪蛋白和标准牛奶的配方奶。
TRIGR 共招募了 5606 名婴儿，其中 2160 名符合入选标准，比目标值 2032 名多 6%。入组的婴儿中，80%接受了研究配方。在最初的 5 年内，总体保留率为 87%，遵守方案的比例为 94%。当最后一名入组的儿童年满 10 岁时（即 2017 年），将打开随机分组代码。
结论/解释：TRIGR 的经验证明了国际饮食干预研究的可行性和成功实施。TRIGR 是首个针对 1 型糖尿病的一级预防试验，如果成功完成，将为该研究问题提供明确答案。
ClinicalTrials.gov NCT00179777
该研究由美国国立儿童健康与人类发展研究所（NICHD）和美国国立糖尿病、消化和肾脏疾病研究所（NIDDK）、美国国立卫生研究院（NIH）（HD040364、HD042444 和 HD051997 号拨款）、加拿大卫生研究院、国际青少年糖尿病研究基金会和欧盟委员会（具体的 RTD 计划“生活质量和资源管理”，合同号 QLK1-2002-00372“糖尿病预防”）资助。其他资金来自 EFSD/JDRF/Novo Nordisk 重点研究资助、芬兰科学院、荷兰糖尿病研究基金会和芬兰糖尿病研究基金会。
