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Keep this study
Lead
University of Colorado, Denver
With
University Hospital Dresden
Diabetes Research Institute, Munich, Germany.
University of Bristol
Juvenile Diabetes Research Foundation
German Federal Ministry of Education and Research
The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.
Age
2–7
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Children aged 2 years to 7 years who:
* Have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs);
* Type 1 diabetes susceptible HLA DR4-DQB1\*0302 or DR4-DQB1\*0304 haplotype and
None of the following HLA DR or DQB1 alleles:
* DR 11
* DR 12
* DQB1\*0602
* DR7-DQB1\*0303
* DR14-DQB1\*0503 or
* Have a sibling with T1DM;
* Identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling;
2. Islet autoantibody negative at time of recruitment.
You may not be if
1. Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
2. Prior or current participation in another intervention trial.
3. Chronic oral steroid use and/or other chronic oral immunosuppressant
