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, Maren Pflüger, Michael Hummel, Ezio Bonifacio, Anette-G Ziegler, Sandra Hummel, Maren Pflüger, Michael Hummel, Ezio Bonifacio, Anette-G Ziegler

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01115621.

Figures

Figure 1
Figure 1
Flowchart of the BABYDIET study population.
Figure 2
Figure 2
Age at first exposure to (A) gluten-containing food, (B) any solid food, and (C) full breastfeeding duration in children randomly assigned to the late-exposure and control groups.
Figure 3
Figure 3
Safety assessments. A: Probability of tTGCAs by Kaplan-Meier analysis in offspring randomly assigned to the BABYDIET late-exposure group (solid line) and the BABYDIET control group (broken line). B: Height (centimeters) and weight (kilograms) development from birth to 36 months of age in offspring randomly assigned to the BABYDIET late-exposure group (solid line) and the BABYDIET control group (broken line).
Figure 4
Figure 4
Outcome analysis. Probability of (A) any islet autoantibody (IAAs, GAD antibodies, and/or IA-2As) and (B) multiple islet autoantibody frequency by Kaplan-Meier analysis in offspring randomly assigned to the BABYDIET late-exposure group (solid line) and the BABYDIET control group (broken line).

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Source: PubMed

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