Treatment with omega-3 polyunsaturated fatty acids does not improve endothelial function in patients with type 2 diabetes and very high cardiovascular risk: A randomized, double-blind, placebo-controlled study (Omega-FMD)

Atherosclerosis. 2018 Apr:271:148-155. doi: 10.1016/j.atherosclerosis.2018.02.030. Epub 2018 Mar 2.

Abstract

Background and aims: Numerous recent studies conducted in different clinical settings have focused on the benefits of omega-3 polyunsaturated fatty acids (n-3 PUFAs) in the prevention of cardiovascular diseases. There is limited evidence that patients with type 2 diabetes (T2D) and very high cardiovascular risk can also benefit from a high dose of n-3PUFAs, especially those on optimal medical therapy as recommended by the guidelines. The aim of the present study was to assess the impact of high-dose n-3 PUFA treatment on endothelial function in patients with T2D and established atherosclerotic cardiovascular disease (ASCVD).

Methods: We conducted a prospective randomized double-blind, placebo-controlled, 2-center study, in which endothelial function was measured using flow-mediated dilation (FMD) and nitroglycerin-mediated dilation (NMD). Serum fatty acids composition was measured by gas chromatography. All measurements were done at baseline and after 3 months of treatment with PUFAs at a dose of 2 g/d (n = 36) or placebo (n = 38).

Results: The majority of the study population was treated with optimal medical therapy. Despite significantly higher concentrations of eicosapentaenoic acid (EPA) and docosahexaenoic acid in the n-3 PUFA group after 3-month treatment, we did not observe significant changes in endothelial function indices (FMD and NMD). However, in regression analysis, only baseline FMD was associated with EPA concentration before 3 months of n-3 PUFA treatment.

Conclusions: Three months of high-dose n-3 PUFA treatment in very high-risk patients with ASCVD and T2D did not improve the endothelial function indices.

Keywords: Atherosclerosis; Cardiovascular disease; Flow-mediated dilation; Omega-3 polyunsaturated fatty acids; Type 2 diabetes.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Atherosclerosis / diagnosis
  • Atherosclerosis / drug therapy*
  • Atherosclerosis / physiopathology
  • Beverages*
  • Brachial Artery / diagnostic imaging
  • Brachial Artery / drug effects*
  • Brachial Artery / physiopathology
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / physiopathology
  • Dietary Supplements* / adverse effects
  • Docosahexaenoic Acids / administration & dosage*
  • Docosahexaenoic Acids / adverse effects
  • Docosahexaenoic Acids / blood
  • Double-Blind Method
  • Eicosapentaenoic Acid / administration & dosage*
  • Eicosapentaenoic Acid / adverse effects
  • Eicosapentaenoic Acid / blood
  • Endothelium, Vascular / diagnostic imaging
  • Endothelium, Vascular / drug effects*
  • Endothelium, Vascular / physiopathology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Poland
  • Prospective Studies
  • Recovery of Function
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vasodilation / drug effects*

Substances

  • Docosahexaenoic Acids
  • Eicosapentaenoic Acid