Trehalose-induced alterations in serum expression levels of microRNAs associated with vascular inflammation in patients with coronary artery disease - the pilot results from the randomized controlled trial.

Introduction Background: This study aimed to investigate the trehalose-induced alterations in serum expression levels of miRNAs associated with vascular inflammation in patients with coronary artery disease (CAD) in order to evaluate the effectiveness of intravenous (IV) trehalose administration in reducing arterial wall inflammation. Material and methods Methods: This trial enrolled 14 men with a history of myocardial infarction (MI) and systemic inflammation. The patients were randomized in a 2:1 ratio to trehalose (15g/week, IV administration) (N=10) or placebo (equal volume 0.9% normal saline) (N=4) for a period of 12-weeks. The relative serum expression levels of miRNA-126, miRNA-24, miRNA-181b, miRNA-10a and miRNA-92a were assessed. Results Results: IV trehalose administration significantly increased the serum level of miRNA-24 (2.473±0.72; P=0.037) compared to the baseline, but did not alter the other miRNA serum levels. However, at the end of the study, miRNA-24 (4.58±0.99; P=0.002), miRNA-181b (4.08±1.75; P=0.009) and miRNA-10a (3.68±0.63; P=0.013) showed notably higher serum levels in the trehalose relative to the placebo group. Furthermore, the reduction (normalized to baseline) in serum levels of miRNA-126 (P=0.042) and miRNA-92a (P=0.001) were reduced in the trehalose versus placebo group, while the serum level of miRNA-24 (P=0.007) was notably higher than that in the placebo group. Conclusions Conclusion: Serum levels of miRNAs associated with vascular inflammation were altered following IV trehalose administration. The alterations in serum miRNAs, especially miRNA-126 and miRNA-24, could be considered as helpful biomarkers for the evaluation of trehalose potency in reducing arterial wall inflammation in patients with CAD.