Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

October 29, 2012 updated by: Mia Jørgensen, Aarhus University Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Neurology, Aarhus University Hospital
        • Contact:
        • Principal Investigator:
          • Henning Andersen, Professor, MD Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.
Time Frame: november 2012 - august 2013
november 2012 - august 2013

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical neurological examination including tendon reflexes, muscle strength and sensation.
Time Frame: november 2012 - august 2013
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
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
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
November 2012 - august 2013

Other Outcome Measures

Outcome Measure
Time Frame
Protein profile of the cerebrospinal fluid using mass spectrometry.
Time Frame: November 2012 - august 2013
November 2012 - august 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Laboratory for Proteome Analysis and Protein Characterization, Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 29, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-470-12.
  • 1-16-02-272-12 (Other Identifier: The Danish Data Protection Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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