Primary dietary intervention study to reduce the risk of islet autoimmunity in children at increased risk for type 1 diabetes: the BABYDIET study

Diabetes Care. 2011 Jun;34(6):1301-5. doi: 10.2337/dc10-2456. Epub 2011 Apr 22.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Autoantibodies / biosynthesis
  • Autoimmunity / genetics*
  • Celiac Disease / etiology
  • Celiac Disease / genetics
  • Child, Preschool
  • Diabetes Mellitus, Type 1 / diet therapy
  • Diabetes Mellitus, Type 1 / etiology
  • Diabetes Mellitus, Type 1 / genetics*
  • GTP-Binding Proteins / immunology
  • Glutens
  • Humans
  • Infant
  • Infant Food
  • Islets of Langerhans / immunology*
  • Pilot Projects
  • Risk Factors
  • Transglutaminases / immunology

Substances

  • Autoantibodies
  • Glutens
  • transglutaminase 2
  • Transglutaminases
  • GTP-Binding Proteins

Associated data

  • ClinicalTrials.gov/NCT01115621