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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 27, 2015
Peripheral Nervous System Diseases
Endocrine System Diseases
Nervous System Diseases