1. Combination of nicotinamide and steroid versus nicotinamide in recent-onset IDDM. The IMDIAB II Study.
- Author
-
Pozzilli P, Visalli N, Boccuni ML, Baroni MG, Buzzetti R, Fioriti E, Signore A, Cavallo MG, Andreani D, and Lucentini L
- Subjects
- Adolescent, Adult, Age Factors, C-Peptide blood, Child, Child, Preschool, Diabetes Mellitus, Type 1 blood, Drug Therapy, Combination, Female, Follow-Up Studies, Glucagon, Glycated Hemoglobin metabolism, Humans, Male, Anti-Inflammatory Agents therapeutic use, Diabetes Mellitus, Type 1 drug therapy, Insulin therapeutic use, Niacinamide therapeutic use, Pregnenediones therapeutic use
- Abstract
Objective: The aim of this study was to compare the effect of nicotinamide (NCT) alone or in combination with a cortisone-like substance, deflazacort (DFL), on the integrated parameters of metabolic control in patients with the recent-onset of insulin-dependent diabetes mellitus (IDDM)., Research Design and Methods: Thirty-six patients who were diagnosed with diabetes between 5 and 35 years of age entered a randomized, double-blind, 1-year prospective study. Group A (n = 18) received NCT for 1 year (25 mg.kg-1.day-1) plus DFL for 3 months (0.6 mg.kg-1.day-1 in the first month, 0.3 mg.kg-1.day-1 in the other 2 months). Group B (n = 18) received NCT for 1 year (25 mg.kg-1.day-1) plus placebo for the first 3 months. All patients were treated with intensified insulin therapy., Results: At 3 months after diagnosis, the insulin dose was significantly higher in group A compared with group B (P < 0.03) with similar HbA1 levels. Basal and stimulated C-peptide levels in group A of both adults and children were significantly higher compared with patients of group B (P < 0.05 and P < 0.03, respectively). At the end of a 1-year follow-up, basal C-peptide did not differ between the two groups, although stimulated C-peptide was still significantly higher in patients of group A compared with group B (P < 0.05). Finally, insulin requirement did not differ between the two groups., Conclusions: A short-term course of DFL therapy at diagnosis in addition to NCT slightly increases glucagon-stimulated but not basal beta-cell function after 1 year.
- Published
- 1994
- Full Text
- View/download PDF