Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
|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
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 or disease|
|Insulin-like Growth Factor I Insulin-like Growth Factor II Diabetes Complications Polyneuropathies Nerve Growth Factors|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
|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
|Patients with unspecified nerve disease|
- Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood. [ Time Frame: november 2012 - august 2013 ]
- 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 ]
- Protein profile of the cerebrospinal fluid using mass spectrometry. [ Time Frame: November 2012 - august 2013 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718015
|Contact: Mia Jørgensen, medical research year student||9194 4232 ext +email@example.com|
|Department of Neurology, Aarhus University Hospital||Not yet recruiting|
|Aarhus, Denmark, 8000|
|Contact: Henning Andersen, Professor, MD Phd firstname.lastname@example.org|
|Principal Investigator: Henning Andersen, Professor, MD Phd|