Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
ClinicalTrials.gov Identifier:
NCT00835757
First received: February 2, 2009
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/ DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy.


Condition
Diabetic Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects. [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The association between DTI parameters and clinical and electrophysiological measures of DPN [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Diabetic peripheral neuropathy
2
Healthy controls

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Two groups of 25 subjects each will be studied: subjects with confirmed diabetic peripheral neuropathy (DPN) and age- and sex-matched healthy controls.

Criteria

Inclusion Criteria:

  1. Presence of diabetes mellitus diagnosed for more than 6 months as defined by the World Health Organization Classification.
  2. Presence of confirmed DPN as defined below.
  3. Age between 18-70 years.
  4. Have no risk factors for other non-diabetic neuropathies (as determined by medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations).
  5. Willingness to provide informed consent and cooperate with the medical procedures for the study.

Inclusion Criteria for Healthy Controls:

  1. Age-matched non-obese (BMI < 30) control subjects
  2. Normal glucose tolerance
  3. Normal blood pressure
  4. Normal lipid profile
  5. Free of any causes of neuropathy as described above.

Exclusion Criteria:

  1. Nursing mothers or pregnant women (excluded by a positive pregnancy test).
  2. Patients with a history of previous kidney, pancreas or cardiac transplantation.
  3. Patients with a past history of neuropathy (independent of diabetes), or with a disease known to be associated with neuropathy (e.g. end stage renal disease, hepatitis C, systemic lupus erythematosus).
  4. Participation in an experimental medication trial within 3 months of starting the study.
  5. Subjects with implantable cardioverter defibrillators and other devices that would preclude MRI scanning.
  6. Subjects who are unable or unwilling to comply with the experimental protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835757

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Rodica Pop-Busui, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Rodica Pop-Busui, Associate Professor of Internal Medicine/MEND, University of Michigan
ClinicalTrials.gov Identifier: NCT00835757     History of Changes
Other Study ID Numbers: 1-2008-1025, JDRF 1-2008-1025
Study First Received: February 2, 2009
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014