Premium
Study design of the Trial to Reduce IDDM in the Genetically at Risk (TRIGR)
Publication year - 2007
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/j.1399-5448.2007.00239.x
Subject(s) - medicine , type 1 diabetes , autoantibody , weaning , incidence (geometry) , hydrolysate , placebo , relative risk , intervention (counseling) , diabetes mellitus , immunology , pediatrics , antibody , endocrinology , alternative medicine , pathology , confidence interval , biochemistry , chemistry , physics , hydrolysis , psychiatry , optics
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.