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Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00835757
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : December 17, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Diabetic Peripheral Neuropathy

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"
Study Start Date : September 2008
Primary Completion Date : June 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Diabetic peripheral neuropathy
2
Healthy controls


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The association between DTI parameters and clinical and electrophysiological measures of DPN [ Time Frame: 12-18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases