Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
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ClinicalTrials.gov Identifier: NCT00835757 |
Recruitment Status
:
Completed
First Posted
: February 4, 2009
Last Update Posted
: December 17, 2013
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Condition or disease |
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Diabetic Peripheral Neuropathy |
Study Type : | Observational |
Actual Enrollment : | 50 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy" |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | December 2012 |

Group/Cohort |
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1
Diabetic peripheral neuropathy
|
2
Healthy controls
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- 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 ]
- The association between DTI parameters and clinical and electrophysiological measures of DPN [ Time Frame: 12-18 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835757
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Rodica Pop-Busui, MD, PhD | University of Michigan |
Responsible Party: | Rodica Pop-Busui, Associate Professor of Internal Medicine/MEND, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00835757 History of Changes |
Other Study ID Numbers: |
1-2008-1025 JDRF 1-2008-1025 |
First Posted: | February 4, 2009 Key Record Dates |
Last Update Posted: | December 17, 2013 |
Last Verified: | December 2013 |
Additional relevant MeSH terms:
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |