Effect of C-Peptide on Diabetic Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1 Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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C-peptide

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lisa Juntti-Berggren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital Solna, Stockholm, Sweden

Locations

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Karolinska University Hospital Solna

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CPSp201

Identifier Type: -

Identifier Source: org_study_id