Study design of the trial to reduce IDDM in the genetically at risk (TRIGR)
2007 (English)In: Pediatric Diabetes, ISSN 1399-543X, E-ISSN 1399-5448, Vol. 8, no 3, 117-137 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2007. Vol. 8, no 3, 117-137 p.
Autoantibodies, hydrolyzed infant formula, primary prevention, type 1 diabetes
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-38340DOI: 10.1111/j.1399-5448.2007.00239.xLocal ID: 43770OAI: oai:DiVA.org:liu-38340DiVA: diva2:259189