The TRIGR Trial: Testing the Potential Link between Weaning Diet and Type 1 Diabetes

In the following we briefly update the information on the study which tests our hypothesized role of the weaning diet in the etiology of type 1 diabetes (T1D), and describe the ongoing Trial to Reduce IDDM in the Genetically at Risk (TRIGR). The study will determine whether weaning to a formula in which cow milk (CM) proteins (the most common intact foreign weaning protein in humans) have been extensively hydrolyzed, reduces risk for T1D in genetically susceptible children. This double blind, randomized controlled trial in subjects with affected first-degree relatives and riskassociated HLA genotypes, requires 2032 eligible infants: 4516 newborn babies need to be recruited, 45% of which are predicted to have eligible HLA genotypes. An international, multicenter consortium has been established comprising 78 centers in 15 countries. By the end of November 2005 we had achieved 81% of the recruitment target with 4396 infants registered, 3896 randomized and 1644 eligible infants entered into the intervention. The 6-8 month intervention is designed to compare the effects of either hydrolyzed casein or standard CM based weaning formula. Duration of breastfeeding is at the mothers' discretion. All subjects are observed for 10 years with measurements of serological markers of intact CM exposure, diabetes predictive autoantibodies (endpoint at age 6 years) and progression to clinical T1D (endpoint at age 10 years). If the intervention is effective in delaying autoimmunity or its progression to diabetes, this first ever primary prevention study of T1D, will have farreaching impact for families with members at risk.