Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

NCT07306884 | Not Yet Recruiting

• 1 other identifier: 09-2025-200567
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabete Mellitus; Peripheral (Sensorimotor) Diabetic Polyneuropathy

Keywords

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

Outcome Measures

Primary Outcomes (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.

  Baseline (single study visit)

Secondary Outcomes (1)

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

  Baseline (single study visit)

Study Arms (3)

Diabetic patients with symptomatic peripheral neuropathy.

OTHER

Diagnostic Test: Nerve conduction study; Diagnostic Test: Nerve ultrasound

Diabetic without any clinical features nor complaints of peripheral neuropathy

OTHER

Diagnostic Test: Nerve conduction study; Diagnostic Test: Nerve ultrasound; Diagnostic Test: Autonomic assessment

Healthy individuals.

OTHER

Diagnostic Test: Nerve conduction study; Diagnostic Test: Nerve ultrasound; Diagnostic Test: Autonomic assessment

Interventions

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.

Diabetic patients with symptomatic peripheral neuropathy.; Diabetic without any clinical features nor complaints of peripheral neuropathy; Healthy individuals.

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

Diabetic without any clinical features nor complaints of peripheral neuropathy; Healthy individuals.

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.

Diabetic patients with symptomatic peripheral neuropathy.; Diabetic without any clinical features nor complaints of peripheral neuropathy; Healthy individuals.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years with type 1 or type 2 diabetes (with or without diabetic peripheral neuropathy), and age and sex-matched healthy controls

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Department of Neurology, Faculty of Medicine,Assiut university

Asyut, Asyut Governorate, 71511, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Peripheral Nervous System Diseases

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Nageh Fouly

  Department of Neurology , Assiut University, Egypt

  STUDY CHAIR

Central Study Contacts

Dalia Galal

CONTACT

+201090463145; daliarageh6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Neurology and Psychiatry Department, Assiut University

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

EG (1)