A multi-centre randomized trial of two different doses of nicotinamide in patients with recent-onset Type 1 diabetes (the IMDIAB VI)
✍ Scribed by Natalia Visalli; Maria G. Cavallo; Alberto Signore; Marco G. Baroni; Raffaella Buzzetti; Elvira Fioriti; Chiara Mesturino; Rossana Fiori; Lucio Lucentini; Maria C. Matteoli; Antonio Crinò; Stefania Corbi; Sabrina Spera; Carlo Teodonio; Francesco Paci; Rita Amoretti; Luigi Pisano; Concetta Suraci; Giuseppe Multari; Nicoletta Sulli; Marco Cervoni; Giancarlo De Mattia; Maria R. Cassone Faldetta; Brunetto Boscherini; Maria L. Manca Bitti; Giovanni Marietti; Federica Ferrazzoli; Carla Bizzarri; Dario Pitocco; Giovanni Ghirlanda; Paolo Pozzilli
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 70 KB
- Volume
- 15
- Category
- Article
- ISSN
- 1520-7552
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✦ Synopsis
Background Intensive insulin therapy is the gold standard by which Type 1 diabetes is treated. In addition to this therapy, administration of nicotinamide (NA) can be bene®cial. This concept is reinforced by the results of a recent meta-analysis of the use of NA in patients with recent-onset Type 1 diabetes.
Methods In this study we compared two different doses of NA in 74 patients with duration of Type 1 diabetes <4 weeks (mean age 13 years). Patients were randomly allocated in blind to two treatment groups: 38 patients received a dose of 25 mg/kg (b.w.) of NA and 36 patients received a dose of 50 mg/kg (b.w.) of NA. Intensive insulin therapy was carried out in order to optimize metabolic control as soon as possible after diagnosis and to maintain blood glucose level as near to normal as possible. Response to therapy was monitored throughout the study by investigating the occurrence of clinical (complete) remission de®ned, according to the recommendations of the International Diabetes Immunotherapy Group, as restoration of normal fasting and post-prandial blood glucose without any insulin administration for more than 2 weeks. Moreover, the integrated measures of metabolic control (C-peptide, HbA 1c and insulin dose) were analysed at 3-month intervals up to 1 year after diagnosis.
Results There were no signi®cant differences in the integrated measures of metabolic control between the two NA treated groups either at onset of the disease or at each 3-month interval up to 1 year after diagnosis, although there was a tendency toward higher insulin dosages in the 50 mg NA group. No signi®cant differences were observed in the rate of clinical remission between the two groups.
Conclusion
We conclude that patients with recent-onset Type 1 diabetes treated with two different doses of NA, in addition to intensive insulin therapy, show similar residual beta-cell function 1 year later. Since both doses of NA are likely to be effective in reducing beta-cell dysfunction, the smaller dose of 25 mg/kg NA would be suf®cient as a higher dose may induce insulin resistance.