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Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

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ClinicalTrials.gov Identifier: NCT01718015
Recruitment Status : Unknown
Verified October 2012 by Mia Jørgensen, Aarhus University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
Information provided by (Responsible Party):
Mia Jørgensen, Aarhus University Hospital

October 29, 2012
October 31, 2012
October 31, 2012
November 2012
August 2013   (Final data collection date for primary outcome measure)
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood. [ Time Frame: november 2012 - august 2013 ]
Same as current
No Changes Posted
  • Clinical neurological examination including tendon reflexes, muscle strength and sensation. [ Time Frame: november 2012 - august 2013 ]
  • Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity) [ Time Frame: november 2012 - august 2013 ]
  • Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg) [ Time Frame: november 2012 - august 2013 ]
  • Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg) [ Time Frame: November 2012 - august 2013 ]
Same as current
Protein profile of the cerebrospinal fluid using mass spectrometry. [ Time Frame: November 2012 - august 2013 ]
Same as current
 
Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Cerebrospinal fluid, plasma and serum
Probability Sample
Patients who have performed a lumbar puncture at Department of Neurology and Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark.
  • Insulin-like Growth Factor I
  • Insulin-like Growth Factor II
  • Diabetes Complications
  • Polyneuropathies
  • Nerve Growth Factors
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
Same as current
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01718015
1-10-72-470-12.
1-16-02-272-12 ( Other Identifier: The Danish Data Protection Agency )
Yes
Not Provided
Not Provided
Mia Jørgensen, Aarhus University Hospital
Aarhus University Hospital
Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
Not Provided
Aarhus University Hospital
October 2012