Status:
COMPLETED
Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-70 years
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 peripher...
Eligibility Criteria
Inclusion
- Presence of diabetes mellitus diagnosed for more than 6 months as defined by the World Health Organization Classification.
- Presence of confirmed DPN as defined below.
- Age between 18-70 years.
- 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).
- Willingness to provide informed consent and cooperate with the medical procedures for the study.
- Inclusion Criteria for Healthy Controls:
- Age-matched non-obese (BMI \< 30) control subjects
- Normal glucose tolerance
- Normal blood pressure
- Normal lipid profile
- Free of any causes of neuropathy as described above.
Exclusion
- Nursing mothers or pregnant women (excluded by a positive pregnancy test).
- Patients with a history of previous kidney, pancreas or cardiac transplantation.
- 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).
- Participation in an experimental medication trial within 3 months of starting the study.
- Subjects with implantable cardioverter defibrillators and other devices that would preclude MRI scanning.
- Subjects who are unable or unwilling to comply with the experimental protocol.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00835757
Start Date
September 1 2008
End Date
December 1 2012
Last Update
December 17 2013
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109