BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk

Type 1 Diabetes Clinical Trial

Official title:

BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01115621
• Other study ID #: ZI310/14-1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2010
• Last updated: April 30, 2010
• Start date: February 2001
• Est. completion date: December 2016

Study information

• Verified date: April 2010
• Source: Institut fur Diabetesforschung, Munich, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Glutenfree diet during the first year of life
Glutenfree diet during the first year of life

Locations

Country	Name	City	State
Germany	Institut für Diabetesforschung	München

Sponsors (1)

Lead Sponsor	Collaborator
Institut fur Diabetesforschung, Munich, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Pflüger 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. — View 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. Epub 2 — View Citation

Winkler C, Hummel S, Pflüger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of dietary intervention on the development of islet autoantibodies	Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.	3 years	No
Secondary	Effect of dietary intervention on the development of Type 1 diabetes.	Secondary outcome is to compare the prevalence of type 1 diabetes between children participating in the dietary intervention and the control group	10 years	No