Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

Completed

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT00835757

Run by

University of Michigan

People needed

50

Starts

2008-09-01

Expected to finish

2012-12-01

Last updated by the study team

2013-12-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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