Clinical trial NCT03934970: Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
Official title: A Study of Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Polyneuropathy
Magnetic Resonance Imaging
Keywords: Diabetic Polyneuropathy
Diffusion tensor imaging
Neuropathy scores
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a case-control study of 30 Egyptian patients with type 2 diabetes mellitus complaining of symptoms suggestive of peripheral neuropathy including 12 males and 18 females with a mean of 50.90 ± 9.18 years and 15 normal healthy Egyptian volunteers including10 males and 5 females with a mean age of 45.67±7.77 years.

Brief summary: This study is a diagnostic accuracy study that aims to evaluate the role of DTI in evaluation of DPN in comparison to clinical scores and nerve conduction studies (NCS). The study included 30 patients with diabetes mellitus complaining of neuropathy symptoms and 15 healthy volunteers. All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score. The values of these tests were compared and correlated and diagnostic accuracy tests were performed together with identification of cut-off score for abnormal diffusion tensor imaging parameters in diabetic neuropathy


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with symptoms suggestive of peripheral neuropathy.

Exclusion Criteria:

* Patients with evidence of nerve entrapment or neuropathy due to causes other than DM

Primary outcomes:
measure: Comparison of diagnostic accuracy of Diffusion tensor imaging in comparison to nerve conduction velocity
timeFrame: Six Months
measure: Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to motor amplitude in diabetic patients.
timeFrame: Six Months
measure: Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to sensory amplitude in diabetic patients.
timeFrame: Six Months
measure: Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Deficit Score in diabetic patients.
timeFrame: Six Months
measure: Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Neuropathy Impairment Score in diabetic patients.
timeFrame: Six Months
measure: Comparison of diagnostic accuracy of Diffusion tensor imaging of peripheral nerves in comparison to Diabetic Neuropathy Examination in diabetic patients.
timeFrame: Six Months
Secondary outcomes:
measure: Identifying cut-off value for abnormal diffusion tensor fractional anisotropy in diabetic neuropathy.
timeFrame: Six months
measure: Identifying cut-off value for abnormal diffusion tensor apparent diffusion coefficient in diabetic neuropathy.
timeFrame: Six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Department of Neurology, Cairo University
name: Ahmed Abdelalim, MD
role: PRINCIPAL_INVESTIGATOR
References: