Primary intervention with mucosal insulin for prevention of type one diabetes in infants at high genetic risk to develop diabetes

Not Applicable

Completed

• Conditions: Type 1 diabetes-associated development of autoimmunity; Nutritional, Metabolic, Endocrine; Insulin dependent diabetes mellitus

• Registration Number: ISRCTN76104595
• Lead Sponsor: Medical Faculty Carl Gustav Carus (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified