BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
Not Applicable
- Conditions
- Type 1 Diabetes
- Interventions
- Other: Glutenfree diet during the first year of life
- Registration Number
- NCT01115621
- Lead Sponsor
- Institut fur Diabetesforschung, Munich, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glutenfree diet Glutenfree diet during the first year of life Glutenfree diet during the first year of life
- Primary Outcome Measures
Name Time Method Effect of dietary intervention on the development of islet autoantibodies 3 years Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.
- Secondary Outcome Measures
Name Time Method Effect of dietary intervention on the development of Type 1 diabetes. 10 years Secondary outcome is to compare the prevalence of type 1 diabetes between children participating in the dietary intervention and the control group
Trial Locations
- Locations (1)
Institut für Diabetesforschung
🇩🇪München, Germany