MedTrace Logo

Omega-3 Fatty Acids Supplementation and Atherothrombotic Biomarkers in Type 2 Diabetes and Cardiovascular Disease.

NCT02178501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2016-11-29

No results posted yet for this study

Summary

The major source of mortality and morbidity of diabetic patients is cardiovascular disease (CVD). Moreover, in CVD patients the presence of diabetes is associated with the increased risk of major adverse cardiac events as compared to patients without diabetes. The pathophysiology of macrovascular complications in T2D is not fully understood and involves: 1/ induction of oxidative stress, 2/ the formation of advanced glycation end products, 3/ activation of blood coagulation and platelet aggregation, 4/ increased inflammation, 5/ altered secretion of adipokines in obese subjects and 6/ endothelial dysfunction. All those mechanisms in T2D patients could potentially be a subject of new therapeutic interventions.

A therapy that continues to show promise in T2D patients with CVD is supplementation with omega-3 polyunsaturated fatty acids (PUFA). Clinical studies have indicated that omega-3 PUFA decrease the risk of major cardiovascular events, although the mechanism of action is not completely understood. Moreover, there were no trials exploring the mechanisms and outcomes of omega-3 treatment in T2D patients with CVD. Despite that fact, Polish Diabetes Association guidelines recommend the use of omega-3 PUFA in patients with diabetes in the prevention of macrovascular complications. Moreover, it is unclear whether the benefits of modifying the pathophysiological processes during supplementation with omega-3 PUFA occur only in patients with their deficiency or in all patients with type 2 diabetes.

Potential benefits of omega-3 PUFA in such patients are: 1/ decreased oxidative stress, 2/ decreased platelet aggregation and reduction of hypercoagulable state, 3/ anti-inflammatory effects, 4/ improvement in endothelial function. All those effects were explored previously with inconsistent findings. There is very limited information from clinical studies on the mechanisms and benefits of omega-3 PUFA in T2D patients with CVD.

The objective of the current study is to evaluate the effects of omega-3 PUFA administered on top of optimal therapy of atherosclerotic vascular disease and T2D on endothelial function, platelet aggregation and thrombotic, inflammatory and oxidative stress biomarkers.

Conditions

Interventions

DIETARY_SUPPLEMENT

Omega-3 PUFA

comparison of omega-3 PUFA supplementation 2000 mg once daily (1000 mg EPA and 1000 mg DHA) versus placebo

Sponsors & Collaborators

  • National Science Centre, Poland

    collaborator OTHER_GOV

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Grzegorz Gajos, prof.assoc. · Department of Coronary Disease, Institute of Cardiology, Jagiellonian University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02178501 on ClinicalTrials.gov