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6. INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Author

Dunger, David B., Bruggraber, Sylvaine F. A., Mander, Adrian P., Marcovecchio, M. Loredana, Tree, Timothy, Chmura, Piotr Jaroslaw, Knip, Mikael, Schulte, Anke M., Mathieu, Chantal, Mathieu, C., Gillard, P., Casteels, K., Overbergh, L., Dunger, D., Wallace, C., Evans, M., Thankamony, A., Hendriks, E., Bruggraber, S., Peakman, M., Tree, T., Morgan, N., Richardson, S., Todd, J., Wicker, L., Mander, A., Dayan, C., Alhadj Ali, M., Pieber, T., Eizirik, D., Cnop, M., Brunak, S., Pociot, F., Johannesen, J., Rossing, P., Legido Quigley, C., Mallone, R., Scharfmann, R., Boitard, C., Knip, M., Otonkoski, T., Veijola, R., Lahesmaa, R., Oresic, M., Toppari, J., Danne, T., Ziegler, A. G., Achenbach, P., Rodriguez-Calvo, T., Solimena, M., Bonifacio, E., Speier, S., Holl, R., Dotta, F., Chiarelli, F., Marchetti, P., Bosi, E., Cianfarani, S., Ciampalini, P., de Beaufort, C., Dahl-Jørgensen, K., Skrivarhaug, T., Joner, G., Krogvold, L., Jarosz-Chobot, P., Battelino, T., Thorens, B., Gotthardt, M., Roep, B., Nikolic, T., Zaldumbide, A., Lernmark, A., Lundgren, M., Costecalde, G., Strube, T., Schulte, A., Nitsche, A., von Herrath, M., Wesley, J., Napolitano-Rosen, A., Thomas, M., Schloot, N., Goldfine, A., Waldron-Lynch, F., Kompa, J., Vedala, A., Hartmann, N., Nicolas, G., van Rampelbergh, J., Bovy, N., Dutta, S., Soderberg, J., Ahmed, S., Martin, F., Agiostratidou, G., Koralova, A., Willemsen, R., Smith, A., Anand, B., Puthi, V., Zac-Varghese, S., Datta, V., Dias, R., Sundaram, P., Vaidya, B., Patterson, C., Owen, K., Piel, B., Heller, S., Randell, T., Gazis, T., Bismuth Reismen, E., Carel, J-C, Riveline, J-P, Gautier, J-F, Andreelli, F., Travert, F., Cosson, E., Penfornis, A., Petit, C., Feve, B., Lucidarme, N., Beressi, J-P, Ajzenman, C., Radu, A., Greteau-Hamoumou, S., Bibal, C., Meissner, T., Heidtmann, B., Toni, S., Rami-Merhar, B., Eeckhout, B., Peene, B., Vantongerloo, N., Maes, T., Gommers, L., Marcovecchio, M.L., Vela, J., Latres, E., Children's Hospital, and HUS Children and Adolescents

Subjects
Trials, Adult, Adolescent, SARS-CoV-2, Prevention, Beta-cell function, COVID-19, Medicine (miscellaneous), Beta-cell Function, C-peptide, Master Protocol, Phase 2, Type 1 Diabetes, Type 1 diabetes, Diabetes Mellitus, Type 1, Treatment Outcome, 3121 General medicine, internal medicine and other clinical medicine, Diabetes Mellitus, Type 1/diagnosis, Master protocol, Humans, Pharmacology (medical), Child, Biomarkers
Abstract

Background The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials. Methods In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow. Discussion The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers.

Published
2022
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9. Children at onset of type 1 diabetes show altered N-glycosylation of plasma proteins and IgG

Author

Rudman, N, Kifer, D, Kaur, S, Simunovic, V, Cvetko, A, Pociot, F, Morahan, G, Gornik, O, Rudman, N, Kifer, D, Kaur, S, Simunovic, V, Cvetko, A, Pociot, F, Morahan, G, and Gornik, O

Abstract

AIMS/HYPOTHESIS: Individual variation in plasma N-glycosylation has mainly been studied in the context of diabetes complications, and its role in type 1 diabetes onset is largely unknown. Our aims were to undertake a detailed characterisation of the plasma and IgG N-glycomes in patients with recent onset type 1 diabetes, and to evaluate their discriminative potential in risk assessment. METHODS: In the first part of the study, plasma and IgG N-glycans were chromatographically analysed in a study population from the DanDiabKids registry, comprising 1917 children and adolescents (0.6-19.1 years) who were newly diagnosed with type 1 diabetes. A follow-up study compared the results for 188 of these participants with those for their 244 unaffected siblings. Correlation of N-glycan abundance with the levels and number of various autoantibodies (against IA-2, GAD, ZnT8R, ZnT8W), as well as with sex and age at diagnosis, were estimated by using general linear modelling. A disease predictive model was built using logistic mixed-model elastic net regression, and evaluated using a 10-fold cross-validation. RESULTS: Our study showed that onset of type 1 diabetes was associated with an increase in the proportion of plasma and IgG high-mannose and bisecting GlcNAc structures, a decrease in monogalactosylation, and an increase in IgG disialylation. ZnT8R autoantibody levels were associated with higher IgG digalactosylated glycan with bisecting GlcNAc. Finally, an increase in the number of autoantibodies (which is a better predictor of progression to overt diabetes than the level of any individual antibody) was accompanied by a decrease in the proportions of some of the highly branched plasma N-glycans. Models including age, sex and N-glycans yielded notable discriminative power between children with type 1 diabetes and their healthy siblings, with AUCs of 0.915 and 0.869 for addition of plasma and IgG N-glycans, respectively. CONCLUSIONS/INTERPRETATION: We defined N-glycan changes

Published
2022

10. High-Throughput Human Complement C3 N-Glycoprofiling Identifies Markers of Early Onset Type 1 Diabetes Mellitus in Children.

Author

Šoić, D, Keser, T, Štambuk, J, Kifer, D, Pociot, F, Lauc, G, Morahan, G, Novokmet, M, Gornik, O, Šoić, D, Keser, T, Štambuk, J, Kifer, D, Pociot, F, Lauc, G, Morahan, G, Novokmet, M, and Gornik, O

Abstract

Recently, it was shown that children at the onset of type 1 diabetes (T1D) have a higher proportion of oligomannose glycans in their total plasma protein N-glycome compared to their healthy siblings. The most abundant complement component, glycoprotein C3, contains two N-glycosylation sites occupied exclusively by this type of glycans. Furthermore, complement system, as well as C3, was previously associated with T1D. It is also known that changes in glycosylation can modulate inflammatory responses, so our aim was to characterize the glycosylation profile of C3 in T1D. For this purpose, we developed a novel high-throughput workflow for human C3 concanavalin A lectin affinity enrichment and subsequent LC-MS glycopeptide analysis which enables protein-specific N-glycosylation profiling. From the Danish Childhood Diabetes Register, plasma samples of 61 children/adolescents newly diagnosed with T1D and 84 of their unaffected siblings were C3 N-glycoprofiled. Significant changes of C3 N-glycan profiles were found. T1D was associated with an increase in the proportion of unprocessed glycan structures with more mannose units. A regression model including C3 N-glycans showed notable discriminative power between children with early onset T1D and their healthy siblings with area under curve of 0.879. This study confirmed our previous findings of plasma high-mannose glycan changes in a cohort of recent onset T1D cases, suggesting the involvement of C3 N-glycome in T1D development. Our C3 glycan-based discriminative model could be valuable in assessment of T1D risk in children.

Published
2022

11. Additional file 1 of Elevated levels of interleukin-12/23p40 may serve as a potential indicator of dysfunctional heart rate variability in type 2 diabetes

Author

Wegeberg, A. M., Okdahl, T., Riahi, S., Ejskjaer, N., Pociot, F., St��rling, J., Brock, B., and Brock, C.

Abstract

Additional file 1: Table S1a. Cardiovascular parameters. Table S1b. Neuroinflammatory parameters. Table S2. Associations between neuroinflammatory markers and neurocardiac function.

Published
2022
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12. Confirmation of novel type 1 diabetes risk loci in families

Author

Cooper, J. D., Howson, J. M. M., Smyth, D., Walker, N. M., Stevens, H., Yang, J. H. M., She, J.-X., Eisenbarth, G. S., Rewers, M., Todd, J. A., Akolkar, B., Concannon, P., Erlich, H. A., Julier, C., Morahan, G., Nerup, J., Nierras, C., Pociot, F., Rich, S. S., and the Type 1 Diabetes Genetics Consortium

Published
2012
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49. Results of the MHC Fine Mapping Workshop

Author

Rich, S. S., Akolkar, B., Concannon, P., Erlich, H., Hilner, J., Julier, C., Morahan, G., Nerup, J., Nierras, C., Pociot, F., and Todd, J. A.

Published
2009

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