Reference : Study design of the Trial to Reduce IDDM in the Genetically Risk (TRIGR)
Scientific journals : Article
Human health sciences : Multidisciplinary, general & others
Study design of the Trial to Reduce IDDM in the Genetically Risk (TRIGR)
Krischer, J. []
De Beaufort, Carine mailto [University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > >]
Pediatric Diabetes
Blackwell Publishing
Yes (verified by ORBilu)
[en] study design ; trial ; IDDM ; genetically risk ; TIGR ; pediatric diabetes ; autoantibodies ; hydrolyzed infant formula ; primary prevention
[en] he 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.
TIGR study group

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