Viewing Study NCT01718015



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Last Modification Date: 2024-10-26 @ 10:58 AM
Study NCT ID: NCT01718015
Status: UNKNOWN
Last Update Posted: 2012-10-31
First Post: 2012-10-29

Brief Title: Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
Sponsor: Aarhus University Hospital
Organization: Aarhus University Hospital

Study Overview

Official Title: Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
Status: UNKNOWN
Status Verified Date: 2012-10
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 andor 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1-16-02-272-12 OTHER The Danish Data Protection Agency None