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

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.

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