Primary Dietary Intervention Study to Reduce the Risk of Islet Autoimmunity in Children at Increased Risk for Type 1 Diabetes

Abstract

OBJECTIVETo 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 METHODSA 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.RESULTSAdherence 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.CONCLUSIONSDelaying 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.

Islet autoantibody phenotypes and incidence in children at increased risk for type 1 diabetes

“…Study population Data from two ongoing German birth cohorts of individuals with a family history of type 1 diabetes born between 1989 and 2000 (BABYDIAB [7]) and between 2000 and 2006 (BABYDIET [8]) were combined for this analysis. Both studies aimed to prospectively examine the natural history of islet autoimmunity and type 1 diabetes.…”

“…A subgroup of 150 children carrying high-risk HLA genotypes participated in the BABYDIET gluten intervention study (ClinicalTrials.gov NCT01115621) to investigate whether delay of exposure to gluten could reduce the risk of developing autoantibodies. The intervention failed to show an effect on islet autoantibody development and all participants continued with follow-up examinations according to the natural history protocol [8]. Detailed descriptions of the design of each study have been reported [7,8].…”

“…The intervention failed to show an effect on islet autoantibody development and all participants continued with follow-up examinations according to the natural history protocol [8]. Detailed descriptions of the design of each study have been reported [7,8]. The studies were approved by the ethics committee of Bavaria, Germany (Bayerische Landesärztekammer no.…”

The Association of Celiac Disease With Other Autoimmune Diseases in Children

“…On the basis of this, they hypothesized that GFD may prevent the occurrence of other autoimmune diseases. However, subsequent studies have not confirmed the protective role of GFD [18,19]. Development of other autoimmune disease is more likely if the CD is diagnosed in young individuals with positive family history of CD [20].…”

Progression from single to multiple islet autoantibodies often occurs soon after seroconversion: implications for early screening

“…This knowledge is important for the design of screening and re-screening strategies. Here we analysed the prospectively followed German BABYDIAB/BABYDIET birth cohort [2,5] to address this.…”