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Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01718015
Enrollment
70
Registered
2012-10-31
Start date
2012-11-30
Completion date
2013-08-31
Last updated
2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
CollaboratorUNKNOWN
Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

MeasureTime frame
Protein profile of the cerebrospinal fluid using mass spectrometry.November 2012 - august 2013

Countries

Denmark

Contacts

Primary ContactMia Jørgensen, medical research year student
mia.jorgensen@studmed.au.dk9194 4232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026