Fr1da Insulin Intervention

• Status: Active, not recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells. The process of autoimmune destruction is identified by circulating islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or periphery in a manner that deletes autoreactive effector T cells or induces regulatory T cells. Immunological tolerance can be achieved by administration of antigen under appropriate conditions. Evidence is now emerging in humans that these approaches may be effective in chronic inflammatory diseases such as multiple sclerosis and allergy. Administration of oral insulin in multiple islet autoantibody-positive children offers the potential for inducing immunological tolerance to beta cells and thereby protect against further development progression to type 1 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Technische Universität München
• Collaborators: Helmholtz Zentrum München; Ludwig-Maximilians - University of Munich; Technische Universität Dresden; The Leona M. and Harry B. Helmsley Charitable Trust
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Written informed consent signed by either parent(s) or legal guardian(s).

2. Children aged 2 years to 12 years.

3. Positive for at least two islet autoantibodies out of autoantibodies to glutamic acid decarboxylase (GAD65), to insulin (IAA), autoantibodies to IA-2 (IA2A), or autoantibodies to zink transporter 8 (ZnT8A) (time between screening sample collection and randomization must not exceed 90 days).

4. Normoglycemia assessed by oral glucose tolerance test (OGTT).

5. Participation in an observational study that regularly monitors diabetes development

Exclusion Criteria:

Participants meeting any of the following criteria will NOT be eligible for inclusion into the study:

1. dysglycaemia or overt hyperglycemia (diabetes)

2. Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators.

3. Current participation in another intervention trial.

4. Any condition that could be associated with poor compliance.