Background: Despite numerous studies on cardioprotective effects of omega-3 polyunsaturated fatty acids (n-3\nPUFAs), there is limited evidence for n-3 PUFA-mediated effects, especially at its higher dose, on cardiovascular risk in\npatients with type 2 diabetes (DM2) and established atherosclerosis.\nPurpose: To investigate the effect of daily treatment with a higher dose (2 g) of n-3 PUFAs on platelet function,\ncoagulation parameters, fibrin clot properties, markers of systemic inflammation and metabolic status, in patients\nwith atherosclerotic vascular disease and DM2 who receive optimal medical therapy.\nMethods: We conducted a prospective, double-blind, placebo-controlled, randomized, double-center study, in\nwhich thrombin generation (plasma thrombogenic potential from automated thrombogram), fibrin clot properties\n(plasma fibrin clot permeability; lysis time), platelet aggregation (light transmission aggregometry with adenosine\ndiphosphate and arachidonic acid used as agonists), HbA1c, insulin level, lipid profiles, leptin and adiponectin levels,\nas well as markers of systemic inflammation (i.e., hsCRP, IL-6, TNF-�±, ICAM-1, VCAM-1, and myeloperoxidase) were\ndetermined at baseline and at 3 months after treatment with 2 g/day of n-3 PUFAs (n = 36) or placebo (n = 38).\nMoreover, we assessed serum fatty acids of the phospholipid fraction by gas chromatography both at baseline and at\nthe end of the study.\nResults: Majority of patients were treated with optimal medical therapy and achieved recommended treatment\ntargets. Despite higher serum levels of eicosapentaenoic acid (EPA) (by 204%; p < 0.001) and docosahexaenoic acid\n(DHA) (by 62%; p < 0.0001) in n-3 PUFA group at the end of treatment no changes in platelet aggregation, thrombin\ngeneration, fibrin clot properties or markers of systemic inflammation were observed. No intergroup differences in the\ninsulin, HbA1c and lipid levels were found at the end of the study. There was no change in adiponectin and leptin in\ninterventional group, however leptin increased in control group (p = 0.01), therefore after study period leptin levels\nwere lower in the interventional group (p = 0.01). Additionally, resolvin D1 did not differ between interventional and\ncontrol group.Conclusions: In conclusion, our study demonstrated that in patients with long-standing, well-controlled DM2 and\natherosclerotic disease the treatment with a high dose of n-3 PUFAs (namely, 1 g/day of EPA and 1 g/day of DHA for\n3 months) does not improve coagulation, metabolic, and inflammatory status when measured with the specified\ntests.
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