title: Primary dietary intervention study to reduce the risk of islet autoimmunity in children at increased risk for type 1 diabetes: the BABYDIET study.
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.
  
  
  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.
authors.affiliation: Institute for Diabetes Research, Helmholtz Zentrum München, Munich, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Hummel
authors.forename: Maren
authors.initials: M
authors.lastname: Pflüger
authors.forename: Michael
authors.initials: M
authors.lastname: Hummel
authors.forename: Ezio
authors.initials: E
authors.lastname: Bonifacio
authors.forename: Anette-G
authors.initials: AG
authors.lastname: Ziegler
mesh_terms: D001323:Autoantibodies / Q000096:biosynthesis; D015551:Autoimmunity / Q000235:genetics*; D002446:Celiac Disease / Q000209:etiology / Q000235:genetics; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000178:diet therapy / Q000209:etiology / Q000235:genetics*; D019204:GTP-Binding Proteins / Q000276:immunology; D005983:Glutens; D006801:Humans; D007223:Infant; D007225:Infant Food; D007515:Islets of Langerhans / Q000276:immunology*; D010865:Pilot Projects; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D012307:Risk Factors; D011503:Transglutaminases / Q000276:immunology
chemical_list: D001323:Autoantibodies; D005983:Glutens; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D011503:Transglutaminases; D019204:GTP-Binding Proteins