Back to resultsBABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
Primary Purpose
Type 1 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Glutenfree diet during the first year of life
Sponsored by
About this trial
This is an interventional prevention trial for 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
Sites / Locations
- Institut für Diabetesforschung
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Glutenfree diet
Control - normal diet
Arm Description
Glutenfree diet during the first year of life
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01115621
First Posted
April 7, 2010
Last Updated
April 30, 2010
Sponsor
Institut fur Diabetesforschung, Munich, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01115621
Brief Title
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
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Institut fur Diabetesforschung, Munich, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glutenfree diet
Arm Type
Active Comparator
Arm Description
Glutenfree diet during the first year of life
Arm Title
Control - normal diet
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Glutenfree diet during the first year of life
Intervention Description
Glutenfree diet during the first year of life
Primary Outcome Measure Information:
Title
Effect of dietary intervention on the development of islet autoantibodies
Description
Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Effect of dietary intervention on the development of Type 1 diabetes.
Description
Secondary outcome is to compare the prevalence of type 1 diabetes between children participating in the dietary intervention and the control group
Time Frame
10 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette G Ziegler, MD
Organizational Affiliation
Institut für Diabetesforschung, München, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut für Diabetesforschung
City
München
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18443841
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.
Results Reference
background
PubMed Identifier
19902403
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.
Results Reference
background
PubMed Identifier
15168019
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.
Results Reference
result
PubMed Identifier
31000755
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.
Results Reference
derived
PubMed Identifier
21515839
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.
Results Reference
derived
PubMed Identifier
21361910
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.
Results Reference
derived
Learn more about this trial
BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
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