Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
NCT ID: NCT01718015
Last Updated: 2012-10-31
Study Results
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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UNKNOWN
70 participants
OBSERVATIONAL
2012-11-30
2013-08-31
Brief Summary
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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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Keywords
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Study Design
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CASE_ONLY
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 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
* Cerebral infections
18 Years
80 Years
ALL
Yes
Sponsors
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Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
UNKNOWN
Aarhus University Hospital
OTHER
Responsible Party
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Mia Jørgensen
Medical Research Year Student
Locations
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Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, Denmark
Countries
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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.
Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
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.
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