Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

Completed

• Conditions: Diabetic Peripheral Neuropathy

• Registration Number: NCT00835757
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-04
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects.	12-18 months

Secondary Outcome Measures

Name	Time	Method
The association between DTI parameters and clinical and electrophysiological measures of DPN	12-18 months

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States