Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
This study has been completed.
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
First received: February 2, 2009
Last updated: December 13, 2013
Last verified: December 2013
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.
Diabetic Peripheral Neuropathy
||Observational Model: Case Control
Time Perspective: Prospective
||Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"
Primary Outcome Measures:
- The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects. [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The association between DTI parameters and clinical and electrophysiological measures of DPN [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
Diabetic peripheral neuropathy
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Two groups of 25 subjects each will be studied: subjects with confirmed diabetic peripheral neuropathy (DPN) and age- and sex-matched healthy controls.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00835757
|University of Michigan
|Ann Arbor, Michigan, United States, 48109 |
University of Michigan
Juvenile Diabetes Research Foundation
||Rodica Pop-Busui, MD, PhD
||University of Michigan
No publications provided
||Rodica Pop-Busui, Associate Professor of Internal Medicine/MEND, University of Michigan
History of Changes
|Other Study ID Numbers:
||1-2008-1025, JDRF 1-2008-1025
|Study First Received:
||February 2, 2009
||December 13, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Peripheral Nervous System Diseases
Endocrine System Diseases
Nervous System Diseases