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

NCT06129526 | Unknown Phase 4 DMC

• 1 other identifier: EPA-UOI 2023
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Type 2; Hypertriglyceridemia; Diabetes Mellitus

Keywords

Atherothrombosis; Biomarkers; Coronary Artery Disease (CAD); Corn oil; Eicosapentaenoic acid; Endothelial cells; Inflammation; Omega-3; Platelets; Polyunsaturated Fatty Acids (PUFAs)

Outcome Measures

Primary Outcomes (2)

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

  The primary composite efficacy endpoint is the percentage (%) change in each participant in plasma levels of triglycerides and markers of inflammation, coagulation, endothelial cell and platelet activation, comparing the placebo supplement and the investigating supplement.

  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.

  The Primary safety endpoint is major bleeding according to BARC (Bleeding Academic Research Consortium) criteria.

  3 months

Secondary Outcomes (6)

• The percentage (%) change in plasma levels of triglycerides.

  3 months

• The percentage (%) change in markers of inflammation.

  3 months

• The percentage (%) change in markers of coagulation.

  3 months

• The percentage (%) change in markers of endothelial cell activation.

  3 months

• The percentage (%) change in markers of platelet activation.

  3 months

Study Arms (3)

EPAVasc 2g

ACTIVE COMPARATOR

Dietary Supplement: EPAVasc

EPAVasc 2g x 2

ACTIVE COMPARATOR

Dietary Supplement: EPAVasc

Corn Oil

PLACEBO COMPARATOR

Dietary Supplement: Corn Oil

Interventions

EPAVasc DIETARY_SUPPLEMENT

EPAVasc: 1,875mg EPA / 125mg DHA / 3.75μg Vitamin D / 12mg tocopherol

EPAVasc 2g; EPAVasc 2g x 2

Corn Oil DIETARY_SUPPLEMENT

Corn Oil

Corn Oil

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ioannina: lead
• LIBYTEC Pharmaceutical S.A.: collaborator

Study Sites (1)

Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina

Ioannina, Epirus, 45110, Greece

Location

Related Publications (30)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertriglyceridemia; Diabetes Mellitus; Thrombosis; Coronary Artery Disease; Inflammation

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Clinical Biochemistry

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)