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

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ClinicalTrials.gov Identifier: NCT02178501
Recruitment Status : Completed
First Posted : June 30, 2014
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
National Science Centre, Poland
Information provided by (Responsible Party):
dr Grzegorz Gajos, Jagiellonian University

Brief 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Cardiovascular Diseases Dietary Supplement: Omega-3 PUFA Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Omega-3 Polyunsaturated Acids Supplementation on Endothelial Function, Oxidative Stress, Platelet Aggregation, Blood Coagulation and Inflammation in Patients With Type 2 Diabetes and Cardiovascular Disease
Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omega-3 PUFA
OMEGA-3 PUFA 2000 mg once daily (1000 mg EPA and 1000 mg DHA)
Dietary Supplement: Omega-3 PUFA
comparison of omega-3 PUFA supplementation 2000 mg once daily (1000 mg EPA and 1000 mg DHA) versus placebo

Placebo Comparator: Placebo
Placebo once daily
Dietary Supplement: Omega-3 PUFA
comparison of omega-3 PUFA supplementation 2000 mg once daily (1000 mg EPA and 1000 mg DHA) versus placebo




Primary Outcome Measures :
  1. Change from Baseline in biomarkers of oxidative stress at 3 months [ Time Frame: From baseline to 3 months ]
    8-iso-prostaglandin F2α, oxidized LDL;

  2. Change from Baseline in coagulation status at 3 months [ Time Frame: From baseline to 3 months ]
    1. Platelet aggregation (induced by 5 and 20 μmol/L of adenosine diphosphate (ADP) and by 0.5 mmol/L of arachidonic acid; light transmittance aggregometry)
    2. Thrombin generation (prothrombin 1.2 fragments, endogenous thrombin potential)
    3. Platelet-fibrin clot strength measurements (thromboelastography)
    4. Fibrin clot properties (permeability and lysis)

  3. Change from Baseline in endothelial function status 3 months [ Time Frame: From baseline to 3 months ]
    1. Flow mediated vasodilation in brachial artery (FMD)
    2. Asymmetric Dimethylarginine (ADMA), ICAM-1, VCAM-1, von Willebrand factor


Secondary Outcome Measures :
  1. Change from Baseline in fatty acids metabolism at 3 months [ Time Frame: From baseline to 3 months ]
    1. Serum Phospholipid Fatty Acids
    2. total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol
    3. adiponectin, leptin

  2. Change from Baseline in glycometabolic control at 3 months [ Time Frame: From baseline to 3 months ]
    1. Fasting glucose, HbA1c 2. Insulin, C-peptide 2. Homeostasis model assessment HOMA-IR


Other Outcome Measures:
  1. Safety Measures [ Time Frame: at 3 months ]
    1. Occurrence of any type of ischemic or bleeding complications
    2. Liver enzymes changes



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • min. 50 years old at screening
  • type 2 of diabetes diagnosed for at least 6 months (regardless of the mode of hypoglycemic therapy)
  • HbA1c ≥ 6,5%
  • concomitant coronary artery disease (with significant, reversible or irreversible myocardial perfusion defect, providing existing ischemia or history of myocardial infarction) or cerebrovascular or peripheral vascular disease (documented with angiography)

Exclusion Criteria:

  • pregnancy
  • type 1 diabetes or poorly controlled T2D (HbA1c > 9.0%)
  • acute myocardial infarction within less than 3 months
  • percutaneous coronary intervention, coronary artery bypass grafting, percutaneous transluminal angioplasty or vascular surgery within less than 1 month
  • acute infection
  • hypertriglyceridemia requiring treatment with omega-3 PUFA
  • active bleeding or any known coagulation or bleeding disorders
  • concomitant chronic anticoagulant therapy
  • platelet count < 100x109/L
  • serum creatinine > 177 μmol/L (2 mg/dL)
  • liver injury (alanine transaminase level > 1.5 times above the upper limit of the reference range)
  • chronic use of nonsteroidal anti-inflammatory drugs other than aspirin
  • daily intake of dietary supplements containing omega-3 PUFA within the past month
  • known sensitivity or allergy to fish or omega-3 fatty acid supplements
  • history of inflammatory disease or vasculitis or corticosteroid therapy
  • active substance abuse
  • history of malignancy (unless disease free for >10 years, or non-melanoma skin carcinoma)
  • projected life-expectancy <12 months due to comorbid condition
  • any abnormal laboratory value or physical finding that according to the investigator may interfere with the interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178501


Locations
Poland
Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
Katowice, Poland, 40-635
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
National Science Centre, Poland
Investigators
Principal Investigator: Grzegorz Gajos, prof.assoc. Department of Coronary Disease, Institute of Cardiology, Jagiellonian University Medical College

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr Grzegorz Gajos, prof.assoc., Jagiellonian University
ClinicalTrials.gov Identifier: NCT02178501     History of Changes
Other Study ID Numbers: 2011/03/B/NZ5/05767
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Keywords provided by dr Grzegorz Gajos, Jagiellonian University:
OMEGA-3 PUFA
type 2 diabetes
cardiovascular diseases

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases