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

Launched by UNIVERSITY OF IOANNINA · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial aims to study the effects of a supplement called Eicosapentaenoic acid (EPA) in patients with type 2 diabetes who are at high risk for heart problems. Specifically, the researchers want to find out if taking EPA can lower fat levels in the blood and improve certain markers that indicate inflammation and blood clotting. Participants will be compared to a group receiving a placebo, which is a fake treatment that looks the same but has no active ingredients.

To be eligible for the study, participants must be at least 50 years old and have type 2 diabetes along with other risk factors for heart disease, such as high blood pressure or low levels of good cholesterol. They should also have specific triglyceride levels that are higher than normal despite following a healthy diet. Anyone interested in joining the study will first need to sign a consent form, and they will be expected to continue their usual diabetes and cholesterol medications throughout the trial. It's important to note that certain health conditions, such as severe heart or liver disease, or a history of certain types of strokes, will prevent people from participating.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: The study will enroll DM-2 patients at high or very high cardiovascular risk, aged ≥ 50 years. Patients should have at least one additional cardiovascular risk factor (such as smoking, hypertension, HDL-cholesterol ≤40 mg/dL for Men, or ≤50mg/dL for Women, high-sensitivity C-reactive protein (hs-CRP)\> 3mg/L, renal dysfunction (CrCl 30-60 mL/min), Ankle-Brachial Index (ABI) \<0.9 (without symptoms of intermittent claudication). In addition, patients enrolled in the study will exhibit triglyceride levels \>135 mg/dL and \<500 mg/dL, despite adherence to the dietary recommendations given for their disease. These recommendations should be followed by all patients during the study. In addition to antidiabetic treatment, patients will receive statin or statin-ezetimibe combination therapy for at least 4 weeks prior to the first visit and should have LDL-cholesterol levels \<100mg/dL. Antidiabetic and hypolipidemic treatment will remain unchanged during the study. All patients will sign a written informed consent prior to their inclusion in the study.
• • Exclusion Criteria
• • 1. Patients with a history (≤ 12 months) of acute coronary syndrome (ACS) or ischemic stroke who are receiving antiplatelet therapy.
• • 2. Patients with peripheral arterial disease or carotid artery disease (\>50% stenosis by DOPPLER ultrasound criteria) receiving antiplatelet therapy.
• • 3. Patients receiving monotherapy with any antiplatelet agent.
• • 4. Patients with atrial fibrillation receiving any anticoagulation, or patients with a history of cardioembolic ischemic stroke or hemorrhagic stroke.
• • 5. Patients with severe heart failure, (NYHA IV).
• • 6. Patients with laboratory or clinically diagnosed severe active liver disease or liver failure (child-Pugh staging, score ≥ 5) or renal failure (eGFR \< 30ml/min).
• • 7. Patients with cancer, receiving any anticancer treatment.
• • 8. Patients who are planned to undergo any surgical procedure.
• • 9. Exclusion criteria will also include a. HbA1c levels \>10.0%, b. history of acute or chronic pancreatitis, c. known hypersensitivity to fish or shellfish or to the components of the study product or placebo.