Type 1 Diabetes
Conditions
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.
Interventions
OTHERGlutenfree diet during the first year of life
Glutenfree diet during the first year of life
Sponsors
Institut fur Diabetesforschung, Munich, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed