An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)

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This is a longitudinal observational study of the relationship between measures of ?-cell function, genotype, immunological phenotype and potential environmental factors over time, in individuals with new onset T1D or first degree relatives at higher risk for T1D due to the presence of auto-antibodi...

This is a longitudinal observational study of the relationship between measures of ?-cell function, genotype, immunological phenotype and potential environmental factors over time, in individuals with new onset T1D or first degree relatives at higher risk for T1D due to the presence of auto-antibodies. It is a multicentre international study involving clinical centres across Europe which is unique in the following ways: The first such collaboration in Europe Novel evaluation of C-peptide/?-cell function using both home dried blood spots and regular hospital mixed meal tolerance tests or oral glucose tolerance tests Identical study procedures across all clinical centres Centralised analysis/storage of clinically relevant samples The creation of a living 'Biobank' whereby participants can be recalled for study on the basis of specific genotype/phenotypes Linkage to innovative study of novel biomarkers to inform future interventional strategies A potential pipeline for future recruitment and consent to novel innovative interventional strategies The study is divided into 2 arms: In arm A, the investigators plan to recruit 1500 newly diagnosed T1D patients within 6 weeks from diagnosis. The last study visit will be planned 2 years from diagnosis or until the end of the study. Therefore, the duration of the study will be approximately 2 years consisting of 5 visits. At baseline, C-peptide and immunophenotyping are evaluated. Follow up consists of regular mixed meal tolerance test (MMTT) and providing blood, urine and stool samples for 'omics', immune, viral and microbiome studies. Home dried blood spots (DBS) pre and post a standardized meal will be collected monthly for the duration of the study. These recruited participants will be included for further observational study, confirmation of potential biomarkers and will ultimately provide a pipeline for future recruitment to interventional studies. In arm B, the investigators plan to screen approximately 4500 unaffected first degree family members across all centres during the first 3 years. The family members will be screened for 4 auto-antibodies (GAD65, IA-2A, IAA, ZnT8A). Unaffected family members who are auto-antibody positive will be followed up for approximately 4 years consisting of visits every 6 months for the first 2 years and then every 12 months until the end of the study. Follow up will consist of regular oral glucose tolerance test (OGTT) and providing blood, urine and stool samples for 'omics', immune, viral and microbiome studies. Home dried blood spots (DBS) will be collected monthly for the duration of the study. Unaffected participants who are auto-antibody negative will be sent annual questionnaires until the end of the study. All study participants will be consented to a living 'Biobank' where we will be able to request participants to be recalled by genotype/phenotype for further studies involving blood, urine and stool samples.

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