Clinical trial NCT01115621: BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
Official title: BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Institut fur Diabetesforschung, Munich, Germany
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 150
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk

Exclusion Criteria:

* If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes

Primary outcomes:
measure: Effect of dietary intervention on the development of islet autoantibodies
timeFrame: 3 years
Secondary outcomes:
measure: Effect of dietary intervention on the development of Type 1 diabetes.
timeFrame: 10 years
Other outcomes:
Locations:
city: München
country: Germany
facility: Institut für Diabetesforschung
Study officials:
affiliation: Institut für Diabetesforschung, München, Germany
name: Anette G Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winkler C, Hummel S, Pfluger M, Ziegler AG, Geppert J, Demmelmair H, Koletzko B. The effect of maternal T1DM on the fatty acid composition of erythrocyte phosphatidylcholine and phosphatidylethanolamine in infants during early life. Eur J Nutr. 2008 Apr;47(3):145-52. doi: 10.1007/s00394-008-0708-9. Epub 2008 Apr 28.
citation: Pfluger M, Winkler C, Hummel S, Ziegler AG. Early infant diet in children at high risk for type 1 diabetes. Horm Metab Res. 2010 Feb;42(2):143-8. doi: 10.1055/s-0029-1241830. Epub 2009 Nov 9.
citation: Schmid S, Buuck D, Knopff A, Bonifacio E, Ziegler AG. BABYDIET, a feasibility study to prevent the appearance of islet autoantibodies in relatives of patients with Type 1 diabetes by delaying exposure to gluten. Diabetologia. 2004 Jun;47(6):1130-1. doi: 10.1007/s00125-004-1420-9. Epub 2004 May 28. No abstract available.
citation: Laimighofer M, Lickert R, Fuerst R, Theis FJ, Winkler C, Bonifacio E, Ziegler AG, Krumsiek J. Common patterns of gene regulation associated with Cesarean section and the development of islet autoimmunity - indications of immune cell activation. Sci Rep. 2019 Apr 18;9(1):6250. doi: 10.1038/s41598-019-42750-5.
citation: Hummel S, Pfluger M, Hummel M, Bonifacio E, Ziegler AG. 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.
citation: Adler K, Mueller DB, Achenbach P, Krause S, Heninger AK, Ziegler AG, Bonifacio E. Insulin autoantibodies with high affinity to the bovine milk protein alpha casein. Clin Exp Immunol. 2011 Apr;164(1):42-9. doi: 10.1111/j.1365-2249.2011.04324.x. Epub 2011 Mar 1.