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Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy - NCT00835757-48109(Clinical Trial 269091)



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City:  Ann Arbor
State:  
MI
Zip Code: 48109
Conditions: Diabetic Peripheral Neuropathy
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.
Study summary:
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.
Study is available at: University of Michigan
Ann Arbor, MI 48109
United States

Primary Contact:
Rodica Pop-Busui, MD, PhD
Email: rpbusui@umich.edu
Phone: 734-647-9809

Secondary Contact:
Rodica Pop-Busui, MD, PhD
Email: rpbusui@umich.edu
Phone: 734-647-9809
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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