Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

NCT ID: NCT01718015

Last Updated: 2012-10-31

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

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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

Keywords

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Vascular Endothelial Growth Factor Brain-Derived Neurothropic Factor Diabetes Mellitus CD-163 Cerebrospinal fluid Peripheral Nervous System Diseases Mass spectrometry

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diabetic polyneuropathy

No interventions assigned to this group

Patients with diabetes without peripheral nerve disorder

No interventions assigned to this group

Patients with polyneuropathies not due to diabetes

No interventions assigned to this group

Patients not suffering from diabetes or nerve disease

Control subjects

No interventions assigned to this group

Patients with unspecified nerve disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratory for Proteome Analysis and Protein Characterization, Aarhus University

UNKNOWN

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mia Jørgensen

Medical Research Year Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurology, Aarhus University Hospital

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Mia Jørgensen, medical research year student

Role: CONTACT

Phone: 9194 4232

Email: [email protected]

Facility Contacts

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Henning Andersen, Professor, MD Phd

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19696031 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22271730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21695763 (View on PubMed)

Other Identifiers

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1-16-02-272-12

Identifier Type: OTHER

Identifier Source: secondary_id

1-10-72-470-12.

Identifier Type: -

Identifier Source: org_study_id