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Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy

This study has been completed.
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: February 2, 2017
Last verified: February 2017
  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 ]
    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 ]
    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 ]
    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 ]
    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).

Enrollment: 115
Study Start Date: May 2013
Study Completion Date: September 2016
Primary Completion Date: September 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Denmark
Department of Endocrinology and Internal Medicine
Aarhus, Denmark, 8000
Department of Neurology
Aarhus, Denmark, 8000
Department of Neurophysiology
Aarhus, Denmark, 8000
MR Centre
Aarhus, Denmark, 8000
Germany
Neurologische Universitätsklinik Heidelberg Abteilung für Neuroradiologie
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Aarhus University Hospital
University of Southern Denmark
Investigators
Principal Investigator: Michael Vaeggemose, MSc Department of Neurology, Aarhus University Hospital
  More Information

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 ( Other Grant/Funding Number: UNIK Partnership )
Study First Received: April 12, 2013
Last Updated: February 2, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017