Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Aarhus University Hospital
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Michael Vaeggemose, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01847937
First received: April 12, 2013
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

This project aims to develop high field MR techniques to detect nerve lesions in diabetic patients. The MRI findings will be compared to results from conventional evaluations and nerve conduction studies to determine the validity as part of a clinical practice.


Condition
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Polyneuropathy
Hereditary Axonal Neuropathy
Hereditary Demyelinated Neuropathy
Polyneuropathy, Inflammatory Demyelinating, Chronic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Increase in magnetic resonance signal intensity of segmented nerves [ Time Frame: within the first 20 days (plus or minus 6 days) after initial MR scan ] [ Designated as safety issue: No ]
    Magnetic resonance neurography signal intensities from the sciatic, peroneal, and sural nerve is increased in diabetic patients with peripheral neuropathy compared to healthy control subjects.


Secondary Outcome Measures:
  • Determine diffusion weighted magnetic resonance values according to neuropathy [ Time Frame: within the first 20 days (plus or minus 6 days) after initial MR scan ] [ Designated as safety issue: No ]
    Diffusion weighted MR provides valuable physiological neuropathy information.

  • Examination of magnetic resoance morphological differences according to neuropathy [ Time Frame: within the first 20 days (plus or minus 6 days) after initial MR scan ] [ Designated as safety issue: No ]
    Magnetic resonance neurography reveal significant variation in nerve lesions of patients with axonal, demyelinated, and diabetic peripheral neuropathy.

  • Correlation of magnetic resoance signal intensity value and nerve conduction thresholds [ Time Frame: within the first 20 days (plus or minus 6 days) after initial MR scan ] [ Designated as safety issue: No ]
    The number of damaged nerve fascicles in the sciatic, peroneal, and sural nerve at diabetic patients examined with magnetic resonance images correlates with diabetic peripheral neuropathy examined with conventional tests, nerve conduction velocity, and quantitative sensory testing.


Biospecimen Retention:   Samples Without DNA

Blood sample less then 250ml to determine Hba1c (blood glucose level).


Estimated Enrollment: 145
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetics Type I non-neuropathic
Diabetics with type 1 diabetes and without neuropathy
Diabetics Type II non-neuropathic
Diabetics with type 2 diabetes without neuropathy
Diabetics Type I neuropathic
Diabetics with type 1 diabetes and neuropathy
Diabetics Type II neuropathic
Diabetics with type 2 diabetes and neuropathy
Hereditary axonal neuropathic
Hereditary demyelinated neuropathic
This will mainly be patients with Chronic inflammatory demyelinating polyneuropathy (CIDP).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

In the 3 year course of the study it is expected to include 90 diabetics with and without neuropathy, 10 patients with hereditary axonal neuropathy and 10 patients with demyelinated neuropathy, as well as 35 healthy control subjects. This amounts to a total of 145 subjects.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes, without neuropathy
  • Clinical diagnosis of type 2 diabetes, without neuropathy
  • Clinical diagnosis of type 1 diabetes, with neuropathy
  • Clinical diagnosis of type 2 diabetes, with neuropathy
  • Clinical diagnosis of hereditary axonal neuropathy
  • Clinical diagnosis of hereditary demyelinised neuropathy
  • Healthy controls who do not use prescription drugs and are of normal weight (BMI between 20 and 30).

Exclusion Criteria:

  • The second cause of the neuropathy.
  • Persons who are under 18.
  • Inability to perform nerve conduction study or magnetic resonance imaging.
  • Patients with liver disease, hypothyroidism, current or past alcohol abuse, rheumatological diseases and vasculitis.
  • Silver Treatment, in diabetics with wounds.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847937

Contacts
Contact: Michael Vaeggemose, MSc 20685041 ext +45 michael.vaeggemose@ki.au.dk
Contact: Henning Andersen, Professor 28864580 ext +45 hennande@rm.dk

Locations
Denmark
Department of Endocrinology and Internal Medicine Not yet recruiting
Aarhus, Denmark, 8000
Contact: Niels Ejskjaer, Ass. Prof.    31239910 ext +45    d270946@dadlnet.dk   
Principal Investigator: Per L. Poulsen, Ass. Prof.         
Department of Neurology Not yet recruiting
Aarhus, Denmark, 8000
Contact: Michael Vaeggemose, MSc    20685041 ext +45    michael.vaeggemose@ki.au.dk   
Contact: Henning Andersen, Professor    28864580 ext +45    hennande@rm.dk   
Principal Investigator: Michael Vaeggemose, MSc         
Department of Neurophysiology Not yet recruiting
Aarhus, Denmark, 8000
Contact: Hatice Tankisi, PhD    78462431 ext +45    hatitank@rm.dk   
Principal Investigator: Hatice Tankisi, PhD         
MR Centre Not yet recruiting
Aarhus, Denmark, 8000
Contact: Steffen Ringgaard, Ass. Prof.    24624855 ext +45    steffen@mr.au.dk   
Sub-Investigator: Steffen Ringgaard, Ass. Prof.         
Principal Investigator: Michael Vaeggemose, MSc         
Germany
Neurologische Universitätsklinik Heidelberg Abteilung für Neuroradiologie Not yet recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Mirko Pham, PhD    62215638305 ext +49    mirko.pham@med.uni-heidelberg.de   
Principal Investigator: Mirko Pham, PhD         
Sponsors and Collaborators
Aarhus University Hospital
University of Southern Denmark
Investigators
Principal Investigator: Michael Vaeggemose, MSc Department of Neurology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Michael Vaeggemose, Research Assistant, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01847937     History of Changes
Other Study ID Numbers: 1-10-72-85-13, VEK: 1-10-72-85-13
Study First Received: April 12, 2013
Last Updated: May 3, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetic Neuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Peripheral Nervous System Diseases
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Polyradiculoneuropathy

ClinicalTrials.gov processed this record on November 25, 2014