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

NCT07794475 | Recruiting Phase 1

• 1 other identifier: ACUC-FP-ASU-REC#435
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain (DPN)

Outcome Measures

Primary Outcomes (1)

• Endothelin-1 levels

  at baseline assessment and at 12 weeks

Secondary Outcomes (4)

• DN4 score (neuropathic pain scale).

  at baseline assessment and at 12 weeks

• Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity

  at baseline assessment and at 12 weeks

• Numeric rating scale for pain assessment

  at baseline assessment and at 12 weeks

• side effects

  every 4 weeks and at the end of the study at 12 weeks.

Study Arms (2)

trimetazidine

EXPERIMENTAL

Drug: Trimetazidine Dihydrochloride Tablets

control

NO INTERVENTION

Interventions

Trimetazidine Dihydrochloride Tablets DRUG

trimetazidine 35 mg oral tablets twice daily

trimetazidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Refaat Azab Metry: lead

Study Sites (1)

National Institute of Diabetes

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Trimetazidine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lamia El Wakeel, PhD

  Faculty of Pharmacy, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)