ABSTRACT
One hundred and thirty eight patients participated in a two-year randomized, double-blind multicentre trial to compare monocomponent human insulin and porcine insulin in the treatment of newly diagnosed insulin dependent diabetic children with respect to development of insulin antibodies, metabolic control and B-cell function. There was no difference between the two patient groups throughout treatment either in the level of IgG insulin binding or the percentage of patients with insulin antibodies (IgG-insulin greater than 0.012 U/l). However, the estimated mean of log insulin binding values in the antibody positive patients alone was significantly lower (p less than 0.05) in the human insulin treated group at all times apart from 1 and 18 months (e.g., human insulin group at one and two years: 0.104 and 0.152 U/l, porcine insulin group at one and two years: 0.162 and 0.212 U/l). The insulin antibodies in both patient groups bound equivalent amounts of human and porcine insulin tracer. Metabolic control, insulin dosage and B-cell function in the two treatment groups were similar throughout the treatment period. It is concluded that in newly diagnosed insulin dependent diabetic children monocomponent human insulin is slightly less immunogenic than monocomponent porcine insulin, and equally effective in overall metabolic control.
Subject(s)
Diabetes Mellitus, Type 1/physiopathology , Insulin Antibodies/analysis , Insulin/therapeutic use , Islets of Langerhans/metabolism , Animals , Blood Glucose/metabolism , C-Peptide/blood , Child , Clinical Trials as Topic , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/immunology , Glycated Hemoglobin/analysis , Humans , Immunoglobulin G/analysis , Multicenter Studies as Topic , Random Allocation , Recombinant Proteins/therapeutic use , SwineABSTRACT
Insulin-dependent (type 1) diabetics, aged 14-17 years, were studied according to two protocols. During a 6-month training period of moderate intensity (six participants) the aerobic work capacity and the erythrocyte insulin binding increased by 19% and 28%, respectively. Glycosylated haemoglobin (HbA1) was not significantly reduced. A 2-week intensive physical training program (10 participants) was associated with a 50% decrease of blood glucose values, which did not last beyond the training period. Plasma ketone bodies were markedly reduced. We conclude that young type 1 diabetics may participate in strenuous, short-term physical training. The improved aerobic work capacity and increased cellular insulin binding observed during training of moderate intensity is of potential benefit in the long-term management of the patients.