Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

ConditionsDiabete Mellitus Peripheral (Sensorimotor) Diabetic Polyneuropathy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorAssiut University

About this trial

Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Other causes of neuropathy (e.g., CIDP, trauma, toxins, vitamin deficiencies), advanced renal failure,thyroid disease,chronic alcohol use, pregnancy,

presence of implanted cardiac devicesthat may interfere with autonomic testing

Trial design

Design model

Parallel

Treatments tested in this trial

Nerve conduction study
Diagnostic test
Nerve conduction studies (NCS) are widely regarded as the gold standard for evaluating large-fiber peripheral nerve function. They measure conduction velocity, latency, and amplitude, providing objective evidence of axonal loss or demyelination. While highly specific, NCS often detect abnormalities only in established diabetic peripheral neuropathy, limiting their sensitivity for early or subclinical disease.
Nerve ultrasound
Diagnostic test
High-resolution ultrasound (HRUS) is a non-invasive imaging tool that allows structural evaluation of peripheral nerves. It can measure cross-sectional area (CSA), visualize fascicular pattern, and detect nerve enlargement or structural abnormalities. In diabetic peripheral neuropathy, HRUS provides complementary information to functional tests and may identify early or subclinical changes.
Autonomic assessment
Diagnostic test
Autonomic testing provides insight into small-fiber and autonomic nervous system function, often impaired early in diabetic peripheral neuropathy. Heart rate variability (HRV) during deep breathing and postural change is a simple, non-invasive method to detect cardiovascular autonomic dysfunction

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: Diabetic patients with symptomatic peripheral neuropathy.Other 2 interventions

Group B: Diabetic without any clinical features nor complaints of peripheral neuropathyOther 3 interventions

Group C: Healthy individuals.Other 3 interventions

Trial outcomes

Primary outcomes

Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy

Percentage of participants with clinically diagnosed diabetic peripheral neuropathy who have abnormal nerve conduction study results (reduced amplitude and/or reduced conduction velocity) at the baseline visit.

Time frame

Baseline (single study visit)

Secondary outcomes

Correlation between tibial nerve cross-sectional area and tibial motor conduction velocity

Correlation coefficient between tibial nerve cross-sectional area measured by high-resolution ultrasound and tibial motor nerve conduction velocity at the baseline visit.

Time frame

Baseline (single study visit)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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