Diabetic Peripheral Neuropathic Pain (DPN)
Conditions
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.
Interventions
trimetazidine 35 mg oral tablets twice daily
Sponsors
Sara Refaat Azab Metry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelin-1 levels | at baseline assessment and at 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORLamia El Wakeel, PhD
Faculty of Pharmacy, Ain Shams University
Outcome results
None listed