Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Diabetes Complications Clinical Trial

Official title:

Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01718015
• Other study ID #: 1-10-72-470-12.
• Secondary ID: 1-16-02-272-12
• Status: Not yet recruiting
• Phase: N/A
• First received: October 29, 2012
• Last updated: October 29, 2012
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2012
• Source: Aarhus University Hospital
• Contact: Mia Jørgensen, medical research year student
• Phone: 9194 4232
• Email: mia.jorgensen[@]studmed.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Data Protection AgencyDenmark: Danish Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Department of Neurology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Laboratory for Proteome Analysis and Protein Characterization, Aarhus University

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257. Review. — View Citation

Andreassen CS, Jakobsen J, Flyvbjerg A, Andersen H. Expression of neurotrophic factors in diabetic muscle--relation to neuropathy and muscle strength. Brain. 2009 Oct;132(Pt 10):2724-33. doi: 10.1093/brain/awp208. Epub 2009 Aug 20. — View Citation

Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Protein profile of the cerebrospinal fluid using mass spectrometry.		November 2012 - august 2013	No
Primary	Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.		november 2012 - august 2013	No
Secondary	Clinical neurological examination including tendon reflexes, muscle strength and sensation.		november 2012 - august 2013	No
Secondary	Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity)		november 2012 - august 2013	No
Secondary	Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg)		november 2012 - august 2013	No
Secondary	Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg)		November 2012 - august 2013	No