Timing of Gluten Introduction and Islet Autoimmunity in Young Children: Updated Results From the BABYDIET Study
- Andreas Beyerlein1,
- Ruth Chmiel1,
- Sandra Hummel1,
- Christiane Winkler1,
- Ezio Bonifacio2,3 and
- Anette-Gabriele Ziegler1,3⇑
- 1Institute of Diabetes Research, Helmholtz Zentrum München, Munich, Germany, and Forschergruppe Diabetes der Technischen Universität München, Munich, Germany
- 2Center for Regenerative Therapies, Dresden University of Technology, Dresden, Germany
- 3Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Munich, Germany
- Corresponding author: Anette-Gabriele Ziegler, .
Early introduction of gluten-containing food has been suspected to increase the risk of autoimmunity associated with type 1 diabetes and celiac disease (1–3). In an intervention study in which we randomized early and late first gluten exposure in children with high genetic risk for type 1 diabetes, we did not find a benefit in delaying gluten exposure with respect to autoimmunity associated with diabetes and celiac disease at age 3 years (4). Here, we report an update containing results from natural follow-up of up to 13 years.
In brief, 150 children younger than 3 months with at least one first-degree relative with type 1 diabetes and one of five specific type 1 diabetes−associated HLA genotypes were recruited between 2000 and 2006 and randomized to first exposure to dietary gluten at age 6 months or delayed until age 12 months. After inclusion, children were followed in 3-month intervals until the age of 3 years and yearly thereafter for efficacy (persistent islet autoantibodies) and safety assessment (4). Islet autoimmunity was defined as the development of persistent autoantibodies to one or more of the antigens insulin, GAD65, IA-2, and Zn-T8. …