UnknownPhase 4

Study of the Efficacy and Safety of EPA in Patients With Type-2 Diabetes

Greece450 participantsStarted 2023-12

Plain-language summary

Investigation of the efficacy and safety of an Eicosapentaenoic acid (EPA) supplement versus a placebo supplement on plasma triglyceride levels as well as inflammatory, thrombotic, endothelial and platelet activation markers, in patients with type-2 diabetes mellitus (DM-2).

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Patients with a history (≤ 12 months) of acute coronary syndrome (ACS) or ischemic stroke who are receiving antiplatelet therapy.
✕. Patients with peripheral arterial disease or carotid artery disease (\>50% stenosis by DOPPLER ultrasound criteria) receiving antiplatelet therapy.
✕. Patients receiving monotherapy with any antiplatelet agent.
✕. Patients with atrial fibrillation receiving any anticoagulation, or patients with a history of cardioembolic ischemic stroke or hemorrhagic stroke.
✕. Patients with severe heart failure, (NYHA IV).
✕. Patients with laboratory or clinically diagnosed severe active liver disease or liver failure (child-Pugh staging, score ≥ 5) or renal failure (eGFR \< 30ml/min).
✕. Patients with cancer, receiving any anticancer treatment.
✕. Patients who are planned to undergo any surgical procedure.

What they're measuring

The percentage (%) change in plasma levels of triglycerides and markers of inflammation, coagulation, endothelial cell and platelet activation.

Timeframe: 3 months

Number of participants who suffer from bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria during the entire follow-up period.

Timeframe: 3 months

Trial details

NCT IDNCT06129526

SponsorUniversity of Ioannina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

View on ClinicalTrials.gov More Diabetes Type 2 trials

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Patients with a history (≤ 12 months) of acute coronary syndrome (ACS) or ischemic stroke who are receiving antiplatelet therapy.
✕. Patients with peripheral arterial disease or carotid artery disease (\>50% stenosis by DOPPLER ultrasound criteria) receiving antiplatelet therapy.
✕. Patients receiving monotherapy with any antiplatelet agent.
✕. Patients with atrial fibrillation receiving any anticoagulation, or patients with a history of cardioembolic ischemic stroke or hemorrhagic stroke.
✕. Patients with severe heart failure, (NYHA IV).
✕. Patients with laboratory or clinically diagnosed severe active liver disease or liver failure (child-Pugh staging, score ≥ 5) or renal failure (eGFR \< 30ml/min).
✕. Patients with cancer, receiving any anticancer treatment.
✕. Patients who are planned to undergo any surgical procedure.

What they're measuring

The percentage (%) change in plasma levels of triglycerides and markers of inflammation, coagulation, endothelial cell and platelet activation.

Timeframe: 3 months

Number of participants who suffer from bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria during the entire follow-up period.

Timeframe: 3 months