Effect of C-Peptide on Diabetic Peripheral Neuropathy

Creative Peptides

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 1

Diabetic Polyneuropathy

Treatments

Drug: C-peptide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00278980

CPSp201

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who have a duration of type 1 diabetes of more than 5 yrs
Subjects who are C-peptide deficient
Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
Subjects who have measurable action potential in the sural nerves
Subjects who have reduced nerve conduction velocity in the sural nerves

Exclusion criteria

Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
Subjects who are transplanted (islet cell, kidney or pancreas)