Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT06129526

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

Diabetes Mellitus Clinical Trial

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

Clinical 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06129526
Study type Interventional
Source University of Ioannina
Contact
Status Not yet recruiting
Phase Phase 4
Start date December 2023
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A