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

November 13, 2023 updated by: Alexandros Tselepis, University of Ioannina

Study of the Effect of Eicosapentaenoic Acid (EPA) on Markers of Atherothrombosis in Patients With Type-2 Diabetes

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The conflicting results of previous clinical trials regarding the clinical efficacy of omega-3 fatty acids, such as the STRENGTH and REDUCE-IT studies, as well as the published comments for the placebo used in the REDUCE-IT study (mineral oil), highlight the need for additional studies (pharmacodynamic, clinical, and basic research studies). The SEASIDE (Study of the Effect of Eicosapentaenoic acid, EPA, on Markers of Atherothrombosis in Patients with Type-2 Diabetes) is a phase 4 clinical study, aiming to investigate the efficacy of the dietary supplement EPAVasc, consisted of 1,875mg EPA / 125mg Docosahexaenoic acid (DHA) / 3.75μg Vitamin D / 12mg tocopherol, in reducing the plasma levels of triglycerides, markers of inflammation, coagulation, and platelet as well as endothelial functionality, in high or very high cardiovascular risk DM-2 patients, as compared with the administration of a placebo dietary supplement (Corn Oil). The safety of administering the above EPA supplementation to these patients will be also investigated. This study is expected to significantly advance the existing knowledge regarding the efficacy of EPA in reducing important cardiovascular risk biomarkers in high or very high cardiovascular risk DM-2 patients.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Epirus
      • Ioannina, Epirus, Greece, 45110
        • Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Corn Oil
Dietary supplement: Corn Oil
Corn Oil
Active Comparator: EPAVasc 2g
Dietary supplement: EPAVasc
EPAVasc: 1,875mg EPA / 125mg DHA / 3.75μg Vitamin D / 12mg tocopherol
Active Comparator: EPAVasc 2g x 2
Dietary supplement: EPAVasc
EPAVasc: 1,875mg EPA / 125mg DHA / 3.75μg Vitamin D / 12mg tocopherol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage (%) change in plasma levels of triglycerides and markers of inflammation, coagulation, endothelial cell and platelet activation.
Time Frame: 3 months
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.
Time Frame: 3 months
The Primary safety endpoint is major bleeding according to BARC (Bleeding Academic Research Consortium) criteria.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage (%) change in plasma levels of triglycerides.
Time Frame: 3 months
The secondary efficacy endpoint is the (%) change in triglyceride levels of each participant.
3 months
The percentage (%) change in markers of inflammation.
Time Frame: 3 months
The secondary efficacy endpoint is the (%) change in markers of inflammation, specifically Interleukin-1beta (IL-1β) (pg/ml) and Interleukin-6 (IL-6) (pg/ml).
3 months
The percentage (%) change in markers of endothelial cell activation.
Time Frame: 3 months
The secondary efficacy endpoint is the (%) change in markers of endothelial cell activation specifically Monocyte Chemotactic Protein-1 (MCP-1) (pg/ml), Vascular Endothelial Cell Adhesion Molecule-1 (VCAM-1) (ng/mL) and von Willebrand Factor (vWF) (mIU/ml).
3 months
The percentage (%) change in markers of platelet activation.
Time Frame: 3 months
The secondary efficacy endpoint is the (%) change in markers of platelet activation specifically soluble P-selectin (sP-selectin) (ng/ml), sCD40L (pg/ml) and Thromboxane A2 (TxA2) (pg/ml).
3 months
Number of participants who suffer from the secondary safety end points which are Atrial fibrillation, Palpitations, Arrhythmias, Heart failure, Pneumonia, Peripheral edema, Diarrhea.
Time Frame: 3 months
Secondary safety endpoints are Atrial fibrillation, Palpitations, Arrhythmias, Heart failure, Pneumonia, Peripheral edema, Diarrhea.
3 months
The percentage (%) change in markers of coagulation.
Time Frame: 3 months
The secondary efficacy endpoint is the (%) change in markers of coagulation specifically Tissue Factor (pg/ml) and Thrombin Time (sec).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Collaborators

LIBYTEC Pharmaceutical S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPA-UOI 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe