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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Effect of Trimetazidine on Endothelin-1 and Clinical Outcomes of Patients With Diabetic Peripheral Neuropathy

Sponsor: Sara Refaat Azab Metry • ClinicalTrials.gov ID: NCT07794475

Registry updated: 2026-08-31
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Description

The goal of this clinical trial is to investigate if trimetazidine can improve clinical outcomes of patients with diabetic peripheral neuropathy. The main questions it aims to answer are: Does trimetazidine improve the symptoms of diabetic peripheral neuropathy? Does trimetazidine affect endothelin-1 levels? Participants in the interventional arm will receive trimetazidine tablets 35 mg twice daily for three months.

Interventions

  • Trimetazidine Dihydrochloride Tablets (Drug)
    trimetazidine 35 mg oral tablets twice daily

Eligibility criteria

Inclusion criteria: * Males or females aged 18-65 years diagnosed with Type 2 Diabetes. * Regular attendance of the outpatient diabetes clinic of national institute of diabetes to ensure adequate follow up, glycemic control and monitor any complication or side effect. * Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test). * Glycated Hgb more than 7% Exclusion criteria: * Patients with autoimmune disorders (Sjogren's syndrome, lupus, rheumatoid arthritis), inherited disorders causing peripheral neuropathy, thyroid diseases, chronic inflammatory demyelinating polyneuropathy, patients undergoing gastroplasty surgery, and cancer patients. * Patients have Parkinson disease or any motor movement disorders * Any clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or other endocrine disease. * Pressure on or injury to the nerves * Patients with kidney (eGFR less than 30 ml/min) or severe liver dysfunction (ALT more than 3x ULN). * Patients with recent history of infection. * Patients with cerebral vascular disease, vasculitis, toxic neuritis, spondyloarthropathy, foot edema or ulcer and diagnosis of other neuromuscular disorders or neurodegenerative diseases. * Use of medications or supplements known to cause peripheral neuropathy. * Patients consuming alcohol, any antioxidant supplements or anti-inflammatory medicines and drug abuse. * Ketoacidosis or hypoglycemia resulting in hospital admission within the last 3 months. * Pregnancy or lactation. * Medical, psychological, behavioral or pharmacological factors interfering with the ability to participate in a trial. * Any known allergy to Trimetazidine

Conditions

Diabetic Peripheral Neuropathic Pain (DPN)

Locations

  • National Institute of Diabetes — Cairo, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record