Study design of the trial to reduce IDDM in the genetically at risk (TRIGR)
Study design of the trial to reduce IDDM in the genetically at risk (TRIGR)
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DOI：
10.1111/j.1399-5448.2007.00239.x
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发表时间：
2007-06-01
影响因子：
3.4
通讯作者：
Krischer, Jeffrey
中科院分区：
文献类型：
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作者：
Krischer, Jeffrey
这项研究的假设是，断奶使用广泛水解的婴儿配方奶粉会降低1型糖尿病（T1D）的发病率，就像在所有相关的动物模型中一样。这将在携带风险相关的人类白细胞抗原基因型和与T1D有一级亲属的儿童中进行测试。该试验将采用双盲、前瞻性、安慰剂控制的干预方案，将酪蛋白水解物与传统的牛奶配方进行比较。第二个目的是确定CM抗体（CM暴露的量度）与糖尿病相关自身抗体之间的关系。为了达到80%的检测能力，在自身抗体和随后的糖尿病发展中，40%的干预诱导差异的检测能力，该研究需要2032名受试者。实现招聘目标需要多中心、国际合作的努力。因此，为此目的，在15个国家成立了一个由78个临床中心组成的国际合作研究小组。
The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes (T1D), as it does in all relevant animal models for the disease. This will be tested in children who carry risk-associated human leukocyte antigen genotypes and have a first-degree relative with T1D. The trial will use a double-blind, prospective, placebo-controlled intervention protocol, comparing casein hydrolysate with a conventional cow's milk (CM)-based formula. A secondary aim is to determine relationships between CM antibodies, a measure of CM exposure, and diabetes-associated autoantibodies. To achieve an 80% power for the detection of a 40% intervention-induced difference in the development of autoantibodies and subsequent diabetes, the study requires 2032 subjects. A multicenter, international, collaborative effort is necessary to achieve recruitment targets. A collaborative international study group of 78 clinical centers in 15 countries has therefore been assembled for this purpose.