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Diabetes Type 2Phase 4SEASIDENCT06129526

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

A Phase 4 study testing EPAVasc and Corn Oil in people with Diabetes Type 2 and Hypertriglyceridemia, run by University of Ioannina at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
EPAVasc and Corn Oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
1 siteGreece
Study dates
Dec 2023to Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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).
Show all 9Show fewer
  • Patients with cancer, receiving any anticancer treatment.
  • Patients who are planned to undergo any surgical procedure.
  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina

    Ioannina, Epirus, 45110

Other trials in Greece

About this study

Official title: 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).

Read the 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.

Being tested
EPAVasc, Corn Oil
Keywords
Atherothrombosis, Biomarkers, Coronary Artery Disease (CAD), Corn oil, Eicosapentaenoic acid, Endothelial cells, Inflammation, Omega-3, Platelets, Polyunsaturated Fatty Acids (PUFAs)
Medical subject headings
Diabetes Mellitus, Type 2, Hypertriglyceridemia, Diabetes Mellitus, Thrombosis, Coronary Artery Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPAVascDietary supplement

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

  • Corn OilDietary supplement

    Corn Oil

Study groups in NCT06129526
Study groupRoleWhat they receive
EPAVasc 2gActive comparatorNot described
Receives: Dietary Supplement: EPAVasc
EPAVasc 2g x 2Active comparatorNot described
Receives: Dietary Supplement: EPAVasc
Corn OilPlacebo comparatorNot described
Receives: Dietary Supplement: Corn Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Secondary outcomes (6)

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

    The secondary efficacy endpoint is the (%) change in triglyceride levels of each participant.

    Measured: 3 months

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

    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).

    Measured: 3 months

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

    The secondary efficacy endpoint is the (%) change in markers of coagulation specifically Tissue Factor (pg/ml) and Thrombin Time (sec).

    Measured: 3 months

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

    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).

    Measured: 3 months

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

    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).

    Measured: 3 months

  6. Number of participants who suffer from the secondary safety end points which are Atrial fibrillation, Palpitations, Arrhythmias, Heart failure, Pneumonia, Peripheral edema, Diarrhea.

    Secondary safety endpoints are Atrial fibrillation, Palpitations, Arrhythmias, Heart failure, Pneumonia, Peripheral edema, Diarrhea.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129526
Sponsor's protocol ID
EPA-UOI 2023
Acronym
SEASIDE
Status last verified
Nov 2023
First submitted
2 Nov 2023
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goel A, Pothineni NV, Singhal M, Paydak H, Saldeen T, Mehta JL. Fish, Fish Oils and Cardioprotection: Promise or Fish Tale? Int J Mol Sci. 2018 Nov 22;19(12):3703. doi: 10.3390/ijms19123703.

    PubMed 30469489

  • Innes JK, Calder PC. Marine Omega-3 (N-3) Fatty Acids for Cardiovascular Health: An Update for 2020. Int J Mol Sci. 2020 Feb 18;21(4):1362. doi: 10.3390/ijms21041362.

    PubMed 32085487

  • Cholewski M, Tomczykowa M, Tomczyk M. A Comprehensive Review of Chemistry, Sources and Bioavailability of Omega-3 Fatty Acids. Nutrients. 2018 Nov 4;10(11):1662. doi: 10.3390/nu10111662.

    PubMed 30400360

  • Yagi S, Fukuda D, Aihara KI, Akaike M, Shimabukuro M, Sata M. n-3 Polyunsaturated Fatty Acids: Promising Nutrients for Preventing Cardiovascular Disease. J Atheroscler Thromb. 2017 Oct 1;24(10):999-1010. doi: 10.5551/jat.RV17013. Epub 2017 Aug 24.

    PubMed 28835582

  • Maki KC, Johns C, Harris WS, Puder M, Freedman SD, Thorsteinsson T, Daak A, Rabinowicz AL, Sancilio FD. Bioequivalence Demonstration for Omega-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance. Clin Ther. 2017 Mar;39(3):652-658. doi: 10.1016/j.clinthera.2017.01.019. Epub 2017 Feb 8.

    PubMed 28189365

  • de Carvalho CCCR, Caramujo MJ. The Various Roles of Fatty Acids. Molecules. 2018 Oct 9;23(10):2583. doi: 10.3390/molecules23102583.

    PubMed 30304860

  • Sherratt SCR, Juliano RA, Mason RP. Eicosapentaenoic acid (EPA) has optimal chain length and degree of unsaturation to inhibit oxidation of small dense LDL and membrane cholesterol domains as compared to related fatty acids in vitro. Biochim Biophys Acta Biomembr. 2020 Jul 1;1862(7):183254. doi: 10.1016/j.bbamem.2020.183254. Epub 2020 Mar 2.

    PubMed 32135144

  • Shibabaw T. Omega-3 polyunsaturated fatty acids: anti-inflammatory and anti-hypertriglyceridemia mechanisms in cardiovascular disease. Mol Cell Biochem. 2021 Feb;476(2):993-1003. doi: 10.1007/s11010-020-03965-7. Epub 2020 Nov 11.

    PubMed 33179122

  • Preston Mason R. New Insights into Mechanisms of Action for Omega-3 Fatty Acids in Atherothrombotic Cardiovascular Disease. Curr Atheroscler Rep. 2019 Jan 12;21(1):2. doi: 10.1007/s11883-019-0762-1.

    PubMed 30637567

  • Calder PC. Mechanisms of action of (n-3) fatty acids. J Nutr. 2012 Mar;142(3):592S-599S. doi: 10.3945/jn.111.155259. Epub 2012 Jan 25.

    PubMed 22279140

  • Kromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group. n-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med. 2010 Nov 18;363(21):2015-26. doi: 10.1056/NEJMoa1003603. Epub 2010 Aug 28.

    PubMed 20929341

  • ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1540-1550. doi: 10.1056/NEJMoa1804989. Epub 2018 Aug 26.

    PubMed 30146932

  • Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, Gibson H, Albert CM, Gordon D, Copeland T, D'Agostino D, Friedenberg G, Ridge C, Bubes V, Giovannucci EL, Willett WC, Buring JE; VITAL Research Group. Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer. N Engl J Med. 2019 Jan 3;380(1):23-32. doi: 10.1056/NEJMoa1811403. Epub 2018 Nov 10.

    PubMed 30415637

  • Fialkow J. Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products. Am J Cardiovasc Drugs. 2016 Aug;16(4):229-239. doi: 10.1007/s40256-016-0170-7.

    PubMed 27138439

  • Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundstrom T, Agrawal R, Menon V, Wolski K, Nissen SE. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2268-2280. doi: 10.1001/jama.2020.22258.

    PubMed 33190147

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EPAVasc and Corn Oil in people with Diabetes Type 2 and Hypertriglyceridemia, run by University of Ioannina at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage (%) change in plasma levels of triglycerides and markers of inflammation, coagulation, endothelial cell and platelet activation. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129526, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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