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C-Peptide Replacement Therapy and Sensory Nerve Function in Type 1 Diabetic Neuropathy

2006; American Diabetes Association; Volume: 30; Issue: 1 Linguagem: Inglês

10.2337/dc06-1274

1935-5548

Karin Ekberg, Tom Brismar, Bo‐Lennart Johansson, Per Lindström, Lisa Juntti‐Berggren, Anders Norrby, Christian Berne, Hans J. Arnqvist, Jan Bolinder, John Wahren,

Biochemical effects in animals

OBJECTIVE—C-peptide replacement in animals results in amelioration of diabetes-induced functional and structural abnormalities in peripheral nerves. The present study was undertaken to examine whether C-peptide administration to patients with type 1 diabetes and peripheral neuropathy improves sensory nerve function. RESEARCH DESIGN AND METHODS—This was an exploratory, double-blinded, randomized, and placebo-controlled study with three study groups that was carried out at five centers in Sweden. C-peptide was given as a replacement dose (1.5 mg/day, divided into four subcutaneous doses) or a dose three times higher (4.5 mg/day) during 6 months. Neurological examination and neurophysiological measurements were performed before and after 6 months of treatment with C-peptide or placebo. RESULTS—The age of the 139 patients who completed the protocol was 44.2 ± 0.6 (mean ± SE) years and their duration of diabetes was 30.6 ± 0.8 years. Clinical neurological impairment (NIA) (score >7 points) of the lower extremities was present in 86% of the patients at baseline. Sensory nerve conduction velocity (SCV) was 2.6 ± 0.08 SD below body height–corrected normal values at baseline and improved similarly within the two C-peptide groups (P < 0.007). The number of patients responding with a SCV peak potential improvement >1.0 m/s was greater in C-peptide–treated patients than in those receiving placebo (P < 0.03). In the least severely affected patients (SCV < 2.5 SD below normal at baseline, n = 70) SCV improved by 1.0 m/s (P < 0.014 vs. placebo). NIA score and vibration perception both improved within the C-peptide–treated groups (P < 0.011 and P < 0.002). A1C levels (7.6 ± 0.1% at baseline) decreased slightly but similarly in C-peptide–and placebo-treated patients during the study. CONCLUSIONS—C-peptide treatment for 6 months improves sensory nerve function in early-stage type 1 diabetic neuropathy.