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

ConditionDiabetic Peripheral Neuropathic Pain (DPN)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSara Refaat Azab Metry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trimetazidine Dihydrochloride Tablets

    Drug

    trimetazidine 35 mg oral tablets twice daily

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: trimetazidineExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sara Refaat Azab Metry

Lead sponsor

Ain Shams University

Sponsor institution

Source ClinicalTrials.gov
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