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Completed

NCT Number: NCT00835757

Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. The association between DTI parameters and clinical and electrophysiological measures of DPN

    Time frame: 12-18 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 4, 2009
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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