Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
2 other identifiers
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2012
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 31, 2012
October 1, 2012
9 months
October 29, 2012
October 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.
november 2012 - august 2013
Secondary Outcomes (4)
Clinical neurological examination including tendon reflexes, muscle strength and sensation.
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
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
Other Outcomes (1)
Protein profile of the cerebrospinal fluid using mass spectrometry.
November 2012 - august 2013
Study Arms (5)
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
Eligibility Criteria
Patients who have performed a lumbar puncture at Department of Neurology and Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark.
You may qualify if:
- 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
You may not qualify if:
- Other causes to the development of polyneuropathy in patients with diabetic polyneuropathy
- Cerebral infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, 8000, Denmark
Related Publications (3)
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.
PMID: 19696031BACKGROUNDAndersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
PMID: 22271730BACKGROUNDDyck 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.
PMID: 21695763BACKGROUND
Biospecimen
Cerebrospinal fluid, plasma and serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Research Year Student
Study Record Dates
First Submitted
October 29, 2012
First Posted
October 31, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 31, 2012
Record last verified: 2012-10