Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 75 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Diabete Mellitus, Peripheral (Sensorimotor) Diabetic Polyneuropathy

Being tested

Nerve conduction study, Nerve ultrasound, Autonomic assessment

Keywords

Diabete Mellitus, Peripheral neuropathy, Neurophysiological studies, Nerve ultrasound, automatic assessment

Medical subject headings

Diabetes Mellitus, Diabetic Neuropathies, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Nerve conduction studyDiagnostic 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 ultrasoundDiagnostic 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 assessmentDiagnostic 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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline (single study visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Dec 2025
2. Study startJan 2026 (estimated)
3. Primary completionJan 2027 (estimated)
4. Study completionFeb 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Diabete MellitusStudies of the same condition, open and under way.
• More trials run by Assiut UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.