Objective
Objectives:
The objectives of this proposal is therefore to develop, refine, validate and standardise assays of existing and novel markers for humoral and cellular anti B-cell autoimmunity with the aim of using these markers as surrogate end-points for IDDM development to be used in future intervention trials in individuals at risk.
Brief description:
Recent advances in immunobiology has made it possible to identify individuals at high risk for development of IDDM, and studies in animal models have clearly shown that IDDM is a preventable disorder. B-cell mass can be preserved by immunointervention after the onset of overt IDDM, and promising pilot studies have indicated that B-cell mass may be protected in individuals at risk by the administration of the B-vitamin nicotinamide. This concept is currently being trialed with concerted action funding from the European Commission in the European Nicotinamide Intervention Trial (ENDIT). Other promising preventive interventive strategies need to be tested in the near future. The pool of individuals in risk is a precious resource and current studydesigns require large number of individuals if development of IDDM in risk individuals is the only outcome parameter. There is therefore an urgent need for development of surrogate end-points of IDDM development, which can provide an outcome measure in smaller samples of individuals and after shorter follow-up periods.
The cellular markers will be studied at different levels of refinement and technical complexity ranging from proliferative and cytokine secretory responses of leukocytes and whole blood cultures in response to non-antigen and antigen specific stimulation, to T-cell reactivity at the clonal cultures in response to non-antigen and antigen specific stimulation, to T-cell reactivity at the clonal level towards defined antigen epitopes. The humoral markers are also tested at different levels of sophistication ranging from determination of number and levels of B-cell related autoantibodies to determination of antibody epitopes, isotypes and idiotypes. The goal of the methodological development is to provide suitable reproducible and robust techniques for the determination of cellular and humoral anti B-cell autoimmunity that can be carried our on material shipped from centres all over Europe and which can be transferred to interested local national centres. The potential of the markers will be evaluated in two different clinical settings:
1. sensitivity and specificity wit regard to insulin induced remission in recent-onset IDDM patients.
2. sensitivity and specificity for development of IDDM in individuals at risk, randomised to either placebo or nicotinamide treatment as part of ENDIT. The proposal offers a unique opportunity to exploit the synergy provided by the proposed partners and the members of the ENDIT network. The proposed program forms a logical basis for a continued European effort to identify in shorter time and using less resources intervention strategies with the ultimate aim of preventing IDDM.
Keywords: insulin-dependent diabetes mellitus; prevention; autoimmunity; cellular immune markers, humoral immune markers; metabolic markers; surrogate end-points; pre-diabetes
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Coordinator
2820 Gentofte
Denmark
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