Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835757
• Other study ID #: 1-2008-1025
• Secondary ID: JDRF 1-2008-1025
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: December 13, 2013
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The association between DTI parameters and clinical and electrophysiological measures of DPN		12-18 months	No