Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
NCT ID: NCT00835757
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2008-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
Diabetic peripheral neuropathy
No interventions assigned to this group
2
Healthy controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Rodica Pop-Busui
Associate Professor of Internal Medicine/MEND
Principal Investigators
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Rodica Pop-Busui, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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JDRF 1-2008-1025
Identifier Type: -
Identifier Source: secondary_id
1-2008-1025
Identifier Type: -
Identifier Source: org_study_id