Type 1 diabetes-associated development of autoimmunity Nutritional, Metabolic, Endocrine Insulin dependent diabetes mellitus
Conditions
Interventions
Current information as of 18/02/2010:
Active arm: insulin given orally at 2.5 mg, 7.5 mg, 22.5 mg, or 67.5 mg daily
Control arm: placebo administered orally
Initial information at time of registratio
maximum 18 months corresponding to expected Pre-POINT study duration).
Sponsors
Medical Faculty Carl Gustav Carus (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/07/2013: 1. Children aged 2 to 7 years who: 1.1. Have a multiplex first degree family history of T1DM (both parents, parent and siblings, or two siblings) and a type 1 diabetes susceptible Human Leukocyte Antigen (HLA) DR4-DQB1*0302 or DR4-DQB1*0304 haplotype and none of the following HLA DR or DQB1 alleles: 1.1.1 DR 11 1.1.2 DR 12 1.1.3 DQB1*0602 1.1.4 DR7-DQB1*0303 1.1.5 DR14-DQB1*0503 1.2. Have a sibling with T1DM and are identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling 2. Islet auto-antibody (IA-2) negative at time of recruitment Previous inclusion criteria: 1. Children aged 2 to 7 years who: 1.1. Have a multiplex first degree family history of T1DM (both parents, parent and siblings, or two siblings) and have one of the following Human Leukocyte Antigen (HLA) genotypes: 1.1.1. DR4- DQA1*0301-DQB1*0302 / DR3- DQA1*0501-DQB1*0201 1.1.2. DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0302 1.1.3. DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0201 1.1.4. DR4- DQA1*0301-DQB1*0302 / DR4- DQA1*0301-DQB1*0304, or 1.2. Have a sibling with T1DM and are identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling 2. Islet auto-antibody (IA-2) negative at time of recruitment
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development of immunity to insulin (Immunoglobulin G [IgG] or Immunoglobulin A [IgA] antibodies, or T-cell response to insulin and/or insulin peptides). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and bioavailability of mucosal insulin 2. Determination of an appropriate route and dose for insulin | — |
Countries
Austria, Germany, Italy, Switzerland, United Kingdom, United States of America
Outcome results
None listed