The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.
The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.
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DOI：
10.1007/s00125-010-1964-9
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发表时间：
2011-03
期刊：
影响因子：
8.2
通讯作者：
Akerblom, H. K.
中科院分区：
文献类型：
--
作者：
Akerblom, H. K.
关键词：
在遗传风险中减少胰岛素依赖型糖尿病的试验（TRIGR）研究旨在确定婴儿期断奶后是否会降低1型糖尿病的风险。研究人群包括新生儿，他们有1型糖尿病的一级亲属，并符合HLA纳入但不排除标准的增加风险。这项研究正在三大洲的15个国家进行。1型糖尿病患者的一级亲属来自糖尿病诊所、糖尿病登记处以及其他内分泌或产科办公室和网站。在出生时使用脐带血或足跟血进行HLA分型，并在2周内将结果发送至研究数据管理部门，以向临床研究中心传达合格性。所有被招募的母亲都被鼓励母乳喂养。干预时间为6 ~ 8个月，并对水解酪蛋白和标准牛乳的断奶配方进行比较。TRIGR招募了5，606名婴儿，其中2，160名合格参与者，比2，032名的目标多6%。在登记的患者中，80%的人接触了研究配方奶粉。前5年的总体留存率为87%，方案依从性为94%。当最后一名招募的儿童年满10岁时，即2017年，将开放随机化代码。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是第一个1型糖尿病一级预防试验，如果成功完成，将为研究问题提供明确的答案。ClinicalTrials.gov 研究由国家儿童健康与发展研究所（NICHD）和国家糖尿病、消化和肾脏疾病研究所（NIDDK），国家卫生研究院（NIH）资助。（授权号HD 040364、HD 042444和HD 051997），加拿大卫生研究院，国际青少年糖尿病研究基金会和欧洲共同体委员会（特定RTD方案“生活质量和生活资源管理”，合同号QLK 1 -2002-00372“糖尿病预防”）。其他资金来自EFSD/JDRF/Novo Nordisk Focused Research Grant，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。本文的在线版本（doi：10.1007/s 00125 -010-1964-9）包括TRIGR写作小组的详细信息，以及研究人员和其他TRIGR工作人员的完整列表，并可供授权用户使用。
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. 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). The online version of this article (doi:10.1007/s00125-010-1964-9) includes details of the TRIGR Writing Group, plus a complete list of investigators and other TRIGR staff members, and is available to authorised users.
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影响因子：
8.2
作者：
Åkerblom, HK;Virtanen, SM;Paronen, J
通讯作者：
Paronen, J
影响因子：
120.7
作者：
Norris, JM;Barriga, K;Rewers, M
通讯作者：
Rewers, M
影响因子：
3.4
作者：
Krischer, Jeffrey
通讯作者：
Krischer, Jeffrey
影响因子：
8.2
作者：
Lorenzen, T;Pociot, F;Nerup, J
通讯作者：
Nerup, J
影响因子：
14.2
作者：
Vaarala, O;Saukkonen, T;Akerblom, HK
通讯作者：
Akerblom, HK