Trimetazidine to help diabetic neuropathy symptoms and endothelin-1 levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the use of trimetazidine dihydrochloride tablets, 35 mg twice daily for three months, in adults with diabetic peripheral neuropathy. The trial will measure clinical outcomes and endothelin-1 levels to see if the drug affects neuropathy symptoms and a vascular biomarker. Participants are adults with type 2 diabetes, confirmed neuropathy, and reasonable glycemic control, recruited from a national diabetes institute. The study includes phase 1 and phase 2 elements to assess safety, tolerability, and preliminary efficacy. Exclusion criteria include autoimmune diseases, certain neurological or cardiac conditions, and other factors that could confound results.

Why it matters

Who can join: the full rules

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

Where it's running

• National Institute of Diabetes
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Lamia El Wakeel, PhD — Faculty of Pharmacy, Ain Shams University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.