Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

• Conditions: Insulin-like Growth Factor II; Polyneuropathies; Nerve Growth Factors; Insulin-like Growth Factor I; Diabetes Complications

• Registration Number: NCT01718015
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP) remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism. The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for development and regeneration of the nervous system. In earlier studies reduced concentrations of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin biopsies have been found in patients with DP.

Purpose: Our purpose is to determine the concentration and biological activity of Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163 (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy control subjects. We will furthermore relate the findings to peripheral nerve function. In addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.

Hypothesis: We hypothesize that DP develops due to reduced concentration and biological activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients without damage to the nervous system and healthy control subjects.

Methods: Study subjects consists of patients from Department of Neurology and Department of Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark, who are having a lumbar puncture performed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Last Update Submitted: 2012-10-29
• Study First Posted: 2012-10-31
• Last Update Posted: 2012-10-31
• Study Start: 2012-11
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with diabetic polyneuropathy
• Patients with diabetes without peripheral nerve disorder
• Patients with polyneuropathies not due to diabetes
• Patients not suffering from diabetes or nerve disease (control subjects)
• Patients with unspecified nerve disease

Exclusion Criteria

• Other causes to the development of polyneuropathy in patients with diabetic polyneuropathy
• Cerebral infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.	november 2012 - august 2013

Secondary Outcome Measures

Name	Time	Method
Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg)	november 2012 - august 2013
Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg)	November 2012 - august 2013
Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity)	november 2012 - august 2013
Clinical neurological examination including tendon reflexes, muscle strength and sensation.	november 2012 - august 2013

Trial Locations

Locations (1)

Department of Neurology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark