caa a22 4500 475772598 CHVBK 20180406123621.0 cr unu---uuuuu 170329e20000801xx s 000 0 eng 10.1007/s001250051482 doi (NATIONALLICENCE)springer-10.1007/s001250051482 No effect of oral insulin on residual beta-cell function in recent-onset Type I diabetes (the IMDIAB VII) [Elektronische Daten] [P. Pozzilli, D. Pitocco, N. Visalli, M. G. Cavallo, R. Buzzetti, A. Crinò, S. Spera, C. Suraci, G. Multari, M. Cervoni, M. L. Manca Bitti, M. C. Matteoli, G. Marietti, F. Ferrazzoli, M. R. Cassone Faldetta, C. Giordano, M. Sbriglia, E. Sarugeri, G. Ghirlanda] Aims/hypothesis. Induction of tolerance to insulin is achievable in animal models of Type I (insulin-dependent) Diabetes mellitus by oral treatment with this hormone, which can lead to prevention of the disease. In the Diabetes Prevention Trial of Type I diabetes (DPT-1), oral insulin is given with the aim of preventing disease insurgence. We investigated whether if given at diagnosis of Type I diabetes in humans, oral insulin can still act as a tolerogen and therefore preserve residual beta-cell function, which is known to be substantial at diagnosis. Methods. A double-blind trial was carried out in patients (mean age ± SD: 14 ± 8 years) with recent-onset Type I diabetes to whom oral insulin (5 mg daily) or placebo was given for 12 months in addition to intensive subcutaneous insulin therapy. A total of 82 patients with clinical Type I diabetes ( < 4 weeks duration) were studied. Basal C peptide and glycated haemoglobin were measured and the insulin requirement monitored every 3 months up to 1 year. Insulin antibodies were also measured in 27 patients treated with oral insulin and in 18 patients receiving placebo at the beginning of the trial and after 3, 6 and 12 months of treatment. Results. The trial was completed by 80 patients. Overall and without distinction between age at diagnosis, at 3, 6, 9 and 12 months baseline mean C-peptide secretion in patients treated with oral insulin did not differ from that of those patients treated with placebo. In patients younger than 15 years a tendency for lower C-peptide values at 9 and 12 months was observed in the oral insulin group. Insulin requirement at 1 year was similar between the two groups as well as the percentage of glycated haemoglobin. Finally, IgG insulin antibodies were similar in the two groups at each time point. Conclusion/interpretation. The results of this study indicate that the addition of 5 mg of oral insulin does not modify the course of the disease in the first year after diagnosis and probably does not statistically affect the humoral immune response against insulin. [Diabetologia (2000) 43: 1000-1004] Springer-Verlag Berlin Heidelberg, 2000 Keywords Type I diabetes nationallicence oral insulin nationallicence insulin antibodies nationallicence prevention nationallicence Pozzilli P. Rome, Italy, IT aut Pitocco D. Rome, Italy, IT aut Visalli N. Rome, Italy, IT aut Cavallo M. G. Rome, Italy, IT aut Buzzetti R. Rome, Italy, IT aut Crinò A. Rome, Italy, IT aut Spera S. Rome, Italy, IT aut Suraci C. Rome, Italy, IT aut Multari G. Rome, Italy, IT aut Cervoni M. Rome, Italy, IT aut Manca Bitti M. L. Rome, Italy, IT aut Matteoli M. C. Rome, Italy, IT aut Marietti G. Rome, Italy, IT aut Ferrazzoli F. Rome, Italy, IT aut Cassone Faldetta M. R. Rome, Italy, IT aut Giordano C. Medical Clinic, University of Palermo, Palermo, Italy, IT aut Sbriglia M. Medical Clinic, University of Palermo, Palermo, Italy, IT aut Sarugeri E. San Raffaele Scientific Institute, University of Milan, Milan, Italy, IT aut Ghirlanda G. Rome, Italy, IT aut https://doi.org/10.1007/s001250051482 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s001250051482 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Pozzilli P. Rome, Italy, IT aut NATIONALLICENCE 700 1- Pitocco D. Rome, Italy, IT aut NATIONALLICENCE 700 1- Visalli N. Rome, Italy, IT aut NATIONALLICENCE 700 1- Cavallo M. G. Rome, Italy, IT aut NATIONALLICENCE 700 1- Buzzetti R. Rome, Italy, IT aut NATIONALLICENCE 700 1- Crinò A. Rome, Italy, IT aut NATIONALLICENCE 700 1- Spera S. Rome, Italy, IT aut NATIONALLICENCE 700 1- Suraci C. Rome, Italy, IT aut NATIONALLICENCE 700 1- Multari G. Rome, Italy, IT aut NATIONALLICENCE 700 1- Cervoni M. Rome, Italy, IT aut NATIONALLICENCE 700 1- Manca Bitti M. L. Rome, Italy, IT aut NATIONALLICENCE 700 1- Matteoli M. C. Rome, Italy, IT aut NATIONALLICENCE 700 1- Marietti G. Rome, Italy, IT aut NATIONALLICENCE 700 1- Ferrazzoli F. Rome, Italy, IT aut NATIONALLICENCE 700 1- Cassone Faldetta M. R. Rome, Italy, IT aut NATIONALLICENCE 700 1- Giordano C. Medical Clinic, University of Palermo, Palermo, Italy, IT aut NATIONALLICENCE 700 1- Sbriglia M. Medical Clinic, University of Palermo, Palermo, Italy, IT aut NATIONALLICENCE 700 1- Sarugeri E. San Raffaele Scientific Institute, University of Milan, Milan, Italy, IT aut NATIONALLICENCE 700 1- Ghirlanda G. Rome, Italy, IT aut Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer