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

被引:162
作者
Hummel, Sandra [1 ,2 ]
Pflueger, Maren [3 ]
Hummel, Michael [3 ]
Bonifacio, Ezio [4 ]
Ziegler, Anette-G [1 ,2 ,3 ]
机构
[1] Helmholtz Zentrum Munchen, Diabet Res Inst, Munich, Germany
[2] Tech Univ Munich, Forschergrp Diabet, Munich, Germany
[3] Helmholtz Zentrum Munchen, Inst Diabet Forsch, Forschergrp Diabet eV, Munich, Germany
[4] Tech Univ Dresden, Deutsch Forschungsgemeinschaft Ctr Regenerat Ther, Dresden, Germany
关键词
GLUTEN-FREE DIET; CELIAC-DISEASE; AUTOANTIBODIES; EXPOSURE; INFANCY; MICE;
D O I
10.2337/dc10-2456
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1301 / 1305
页数:5
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