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NCT Number: NCT07794475

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimetazidine Dihydrochloride Tablets

Drug

trimetazidine 35 mg oral tablets twice daily

Primary outcomes

  1. Endothelin-1 levels

    Time frame: at baseline assessment and at 12 weeks

Secondary outcomes

  1. DN4 score (neuropathic pain scale).

    Time frame: at baseline assessment and at 12 weeks

  2. Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity

    Time frame: at baseline assessment and at 12 weeks

  3. Numeric rating scale for pain assessment

    Time frame: at baseline assessment and at 12 weeks

  4. side effects

    Time frame: every 4 weeks and at the end of the study at 12 weeks.

Sponsors and collaborators

Lead sponsor

Sara Refaat Azab Metry

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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