Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.
It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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