The Environmental Determinants of Diabetes in the Young (TEDDY) Study TEDDY Study Group
The Environmental Determinants of Diabetes in the Young (TEDDY) Study TEDDY Study Group
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DOI：
10.1196/annals.1447.062
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发表时间：
2008-01-01
期刊：
影响因子：
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通讯作者：
Rewers, Marian
中科院分区：
文献类型：
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作者：
Rewers, Marian
1型糖尿病（T1 D）的病因仍不清楚，但越来越多的证据表明感染因子和/或儿童早期饮食成分。美国国立卫生研究院已经建立了由美国和欧洲的六个临床中心组成的TEDDY研究联盟，以及一个数据协调中心，以确定易患或预防胰岛自身免疫和T1 D的环境因素。从2004年到2009年，TEDDY将对来自普通人群和已受T1 D影响的家庭的360，000多名新生儿进行筛查，以确定估计17，804名具有高风险HLA-DR，DQ基因型的儿童。其中，7，801人（788名一级亲属和7，013名无T1 D家族史的新生儿）将在4.5个月前开始进行前瞻性随访。截至2008年5月，TEDDY已经筛查了超过25万名新生儿，并招募了近5,000名婴儿-约占最终队列的70%。受试者每3个月就诊一次，直至4岁，随后每6个月就诊一次，直至受试者年满15岁。在每次访视时采集血液样本，用于检测候选感染因子和营养生物标志物;每月采集粪便样本用于检测感染因子。这些样本保存在中央存储库中。主要终点包括（1）在连续两次访视时确认的一种或多种胰岛自身抗体（针对胰岛素、GAD 65或IA-2）的出现;（2）T1 D的发生。到15岁时，估计有800名儿童将发生胰岛自身免疫，400名将进展为T1 D; 67名和27名儿童已经达到这些终点。
The etiology of type 1 diabetes (T1D) remains unknown, but a growing body of evidence points to infectious agents and/or components of early childhood diet. The National Institutes of Health has established the TEDDY Study consortium of six clinical centers in the United States and Europe and a data coordinating center to identify environmental factors predisposing to, or protective against, islet autoimmunity and T1D. From 20042009, TEDDY will screen more than 360,000 newborns from both the general population and families already affected by T1D to identify an estimated 17,804 children with high-risk HLA-DR, DQ genotypes. Of those, 7,801 (788 first-degree relatives and 7,013 newborns with no family history of T1D) will be enrolled in prospective follow-up beginning before the age of 4.5 months. As of May 2008, TEDDY has screened more than 250,000 newborns and enrolled nearly 5,000 infants-approximately 70% of the final cohort. Participants are seen every 3 months up to 4 years of age, with subsequent visits every 6 months until the subject is 15 years of age. Blood samples are collected at each visit for detection of candidate infectious agents and nutritional biomarkers; monthly stool samples are collected for infectious agents. These samples are saved in a central repository. Primary endpoints include (1) appearance of one or more islet autoantibodies (to insulin, GAD65 or IA-2) confirmed at two consecutive visits; (2) development of T1D. By age 15, an estimated 800 children will develop islet autoimmunity and 400 will progress to T1D; 67 and 27 children have already reached these endpoints.