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- Title
No effect of oral insulin on residual beta-cell function in recent-onset Type I diabetes (the IMDIAB VII).
- Authors
Pozzilli, P.; Pitocco, D.; Visalli, N.; Cavallo, M. G.; Buzzetti, R.; Crinò, A.; Spera, S.; Suraci, C.; Multari, G.; Cervoni, M.; Bitti, M. L. Manca; Matteoli, M. C.; Marietti, G.; Ferrazzoli, F.; Faldetta, M. R. Cassone; Giordano, C.; Sbriglia, M. R; Sarugeri, E.; Ghirlanda, G.
- Abstract
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]
- Subjects
INSULIN; HYPOGLYCEMIC agents; INSULIN antibodies; INSULIN resistance; DIABETES; ENDOCRINE diseases
- Publication
Diabetologia, 2000, Vol 43, Issue 8, p1000
- ISSN
0012-186X
- Publication type
Article
- DOI
10.1007/s001250051482