[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654011":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":11,"studyPopulation":11,"armGroups":29,"interventions":38,"overallOfficials":44,"centralContacts":11,"locations":49,"responsibleParty":68,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Endothelin-1 levels",null,"at baseline assessment and at 12 weeks",[14,16,18,20],{"measure":15,"description":11,"timeFrame":12},"DN4 score (neuropathic pain scale).",{"measure":17,"description":11,"timeFrame":12},"Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity",{"measure":19,"description":11,"timeFrame":12},"Numeric rating scale for pain assessment",{"measure":21,"description":11,"timeFrame":22},"side effects","every 4 weeks and at the end of the study at 12 weeks.",{"allocation":24,"interventionModel":25,"interventionModelDescription":11,"primaryPurpose":26,"observationalModel":11,"timePerspective":11,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":11,"whoMasked":11},"NONE",[30,35],{"label":31,"type":32,"description":11,"interventionNames":33},"trimetazidine","EXPERIMENTAL",[34],"Drug: Trimetazidine Dihydrochloride Tablets",{"label":36,"type":37,"description":11,"interventionNames":11},"control","NO_INTERVENTION",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"DRUG","Trimetazidine Dihydrochloride Tablets","trimetazidine 35 mg oral tablets twice daily",[31],[45],{"name":46,"affiliation":47,"role":48},"Lamia El Wakeel, PhD","Faculty of Pharmacy, Ain Shams University","PRINCIPAL_INVESTIGATOR",[50],{"facility":51,"status":52,"city":53,"state":11,"zip":11,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"National Institute of Diabetes","RECRUITING","Cairo","Egypt","EG",{"type":57,"coordinates":58},"Point",[59,60],31.24967,30.06263,{"lat":60,"lon":59},[63],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Sara R A Metry","CONTACT","+201061743901","sara_azab@pharma.asu.edu.eg",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Sara Refaat Azab Metry","Lecturer","100654011","phase-1-effect-of-trimetazidine-on-endothelin-1-and-clinical-outcomes-of-patients-with-diabetic-peripheral-neuropathy-100654011",false,"NCT07794475","Effect of Trimetazidine on Endothelin-1 and Clinical Outcomes of Patients With Diabetic Peripheral Neuropathy","Inclusion criteria:\n\n* Males or females aged 18-65 years diagnosed with Type 2 Diabetes.\n* 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.\n* Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).\n* Glycated Hgb more than 7%\n\nExclusion criteria:\n\n* 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.\n* Patients have Parkinson disease or any motor movement disorders\n* Any clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or other endocrine disease.\n* Pressure on or injury to the nerves\n* Patients with kidney (eGFR less than 30 ml\u002Fmin) or severe liver dysfunction (ALT more than 3x ULN).\n* Patients with recent history of infection.\n* Patients with cerebral vascular disease, vasculitis, toxic neuritis, spondyloarthropathy, foot edema or ulcer and diagnosis of other neuromuscular disorders or neurodegenerative diseases.\n* Use of medications or supplements known to cause peripheral neuropathy.\n* Patients consuming alcohol, any antioxidant supplements or anti-inflammatory medicines and drug abuse.\n* Ketoacidosis or hypoglycemia resulting in hospital admission within the last 3 months.\n* Pregnancy or lactation.\n* Medical, psychological, behavioral or pharmacological factors interfering with the ability to participate in a trial.\n* Any known allergy to Trimetazidine","ALL","18 Years","65 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","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:\n\nDoes trimetazidine improve the symptoms of diabetic peripheral neuropathy? Does trimetazidine affect endothelin-1 levels?\n\nParticipants in the interventional arm will receive trimetazidine tablets 35 mg twice daily for three months.",[90],"Diabetic Peripheral Neuropathic Pain (DPN)","2026-08-27",{"date":93,"type":94},"2026-08-31","ACTUAL",{"date":96,"type":94},"2026-08-01",{"date":98,"type":83},"2027-02",{"name":70,"class":6},1]