- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07794475
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Cairo, Egypt
- Rekruttering
- National Institute of Diabetes
-
Ta kontakt med:
- Sara R A Metry
- Telefonnummer: +201061743901
- E-post: sara_azab@pharma.asu.edu.eg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: styre
|
|
|
Eksperimentell: trimetazidine
|
trimetazidine 35 mg oral tablets twice daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Endothelin-1 levels
Tidsramme: at baseline assessment and at 12 weeks
|
at baseline assessment and at 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
DN4 score (neuropathic pain scale).
Tidsramme: at baseline assessment and at 12 weeks
|
at baseline assessment and at 12 weeks
|
|
Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity
Tidsramme: at baseline assessment and at 12 weeks
|
at baseline assessment and at 12 weeks
|
|
Numeric rating scale for pain assessment
Tidsramme: at baseline assessment and at 12 weeks
|
at baseline assessment and at 12 weeks
|
|
side effects
Tidsramme: every 4 weeks and at the end of the study at 12 weeks.
|
every 4 weeks and at the end of the study at 12 weeks.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Lamia El Wakeel, PhD, Faculty of Pharmacy, Ain Shams University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACUC-FP-ASU-REC#435
Plan for individuelle deltakerdata (IPD)
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