Primary Dietary Intervention Study to Reduce the Risk of Islet Autoimmunity in Children at Increased Risk for Type 1 Diabetes
The BABYDIET study
- Sandra Hummel, PHD1,2,
- Maren Pflüger, PHD3,
- Michael Hummel, MD3,
- Ezio Bonifacio, PHD4 and
- Anette-G. Ziegler, MD1,2,3⇓
- 1Institute for Diabetes Research, Helmholtz Zentrum München, Munich, Germany
- 2Forschergruppe Diabetes der Technischen Universität München, Munich, Germany
- 3Institut für Diabetesforschung der Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Munich, Germany
- 4Deutsche Forschungsgemeinschaft Center for Regenerative Therapies Dresden, Technische Universität Dresden
- Corresponding author: Anette-G. Ziegler, .
OBJECTIVE To determine whether delaying the introduction of gluten in infants with a genetic risk of islet autoimmunity is feasible, safe, and may reduce the risk of type 1 diabetes–associated islet autoimmunity.
RESEARCH DESIGN AND METHODS A total of 150 infants with a first-degree family history of type 1 diabetes and a risk HLA genotype were randomly assigned to a first gluten exposure at age 6 months (control group) or 12 months (late-exposure group) and were followed 3 monthly until the age of 3 years and yearly thereafter for safety (for growth and autoantibodies to transglutaminase C [TGCAs]), islet autoantibodies to insulin, GAD, insulinoma-associated protein 2, and type 1 diabetes.
RESULTS Adherence to the dietary-intervention protocol was reported from 70% of families. During the first 3 years, weight and height were similar in children in the control and late-exposure groups, as was the probability of developing TGCAs (14 vs. 4%; P = 0.1). Eleven children in the control group and 13 children in the late-exposure group developed islet autoantibodies (3-year risk: 12 vs. 13%; P = 0.6). Seven children developed diabetes, including four in the late-exposure group. No significant differences were observed when children were analyzed as per protocol on the basis of the reported first gluten exposure of the children.
CONCLUSIONS Delaying gluten exposure until the age of 12 months is safe but does not substantially reduce the risk for islet autoimmunity in genetically at-risk children.
This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc10-2456/-/DC1.
- Received December 29, 2010.
- Accepted March 22, 2011.
- © 2011 by the American Diabetes Association.
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