Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

This study is not yet open for participant recruitment.
Verified October 2012 by Aarhus University Hospital
Sponsor:
Collaborator:
Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
Information provided by (Responsible Party):
Mia Jørgensen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01718015
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood. [ Time Frame: november 2012 - august 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical neurological examination including tendon reflexes, muscle strength and sensation. [ Time Frame: november 2012 - august 2013 ] [ Designated as safety issue: No ]
  • Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity) [ Time Frame: november 2012 - august 2013 ] [ Designated as safety issue: No ]
  • Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg) [ Time Frame: november 2012 - august 2013 ] [ Designated as safety issue: No ]
  • Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg) [ Time Frame: November 2012 - august 2013 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Protein profile of the cerebrospinal fluid using mass spectrometry. [ Time Frame: November 2012 - august 2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cerebrospinal fluid, plasma and serum


Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients who have performed a lumbar puncture at Department of Neurology and Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718015

Contacts
Contact: Mia Jørgensen, medical research year student 9194 4232 ext +45 mia.jorgensen@studmed.au.dk

Locations
Denmark
Department of Neurology, Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Henning Andersen, Professor, MD Phd       hennande@rm.dk   
Principal Investigator: Henning Andersen, Professor, MD Phd         
Sponsors and Collaborators
Aarhus University Hospital
Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
  More Information

Publications:
Responsible Party: Mia Jørgensen, Medical Research Year Student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01718015     History of Changes
Other Study ID Numbers: 1-10-72-470-12., 1-16-02-272-12
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: Denmark: Danish Data Protection Agency
Denmark: Danish Research Ethics Committee

Keywords provided by Aarhus University Hospital:
Vascular Endothelial Growth Factor
Brain-Derived Neurothropic Factor
Diabetes Mellitus
CD-163
Cerebrospinal fluid
Peripheral Nervous System Diseases
Mass spectrometry

Additional relevant MeSH terms:
Diabetes Mellitus
Polyneuropathies
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014