BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
NCT ID: NCT01115621
Last Updated: 2010-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2001-02-28
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Glutenfree diet
Glutenfree diet during the first year of life
Glutenfree diet during the first year of life
Glutenfree diet during the first year of life
Control - normal diet
No interventions assigned to this group
Interventions
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Glutenfree diet during the first year of life
Glutenfree diet during the first year of life
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
ALL
Yes
Sponsors
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Institut fur Diabetesforschung, Munich, Germany
OTHER
Responsible Party
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Institut fuer Diabetesforschung, Ingolstädter Landstr. 1, Neuherberg
Principal Investigators
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Anette G Ziegler, MD
Role: PRINCIPAL_INVESTIGATOR
Institut für Diabetesforschung, München, Germany
Locations
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Institut für Diabetesforschung
München, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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ZI310/14-1
Identifier Type: -
Identifier Source: org_study_id
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