Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

NCT00835757 | Completed

• 2 other identifiers: 1-2008-1025JDRF 1-2008-1025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The association between DTI parameters and clinical and electrophysiological measures of DPN

  12-18 months

Study Arms (2)

1

Diabetic peripheral neuropathy

2

Healthy controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Rodica Pop-Busui, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine/MEND

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: September 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)