Modulation of circulating extracellular vesicles by antihyperglycemic therapies: A pilot randomized controlled trial
Abstract
AIMS
Circulating extracellular vesicles (EVs) are emerging biomarkers of vascular dysfunction in diabetes. However, the impact of different antihyperglycemic treatments on EV profiles in individuals with type 2 diabetes (T2D) remains poorly investigated. This study aimed to compare circulating EV concentration between individuals with T2D and healthy controls, and to evaluate the effects of liraglutide, empagliflozin, and gliclazide on EV subpopulations.
METHODS
In this single-centre clinical study, we enrolled 60 individuals with T2D and 20 healthy controls. Baseline concentrations of total, endothelial- (CD31+/CD41-), platelet- (CD31+/CD41+), and leukocyte-derived (CD45+) EVs were measured by flow cytometry on whole blood. In the interventional phase, sixty individuals with T2D were randomized to receive liraglutide (n = 20), empagliflozin (n = 20), or gliclazide (n = 20), in add on to metformin, for 12 weeks. EV subpopulations were assessed as exploratory mechanistic outcomes, alongside metabolic parameters, which were re-assessed post-treatment.
RESULTS
At baseline, individuals with T2D had significantly higher concentrations of total, endothelial-, and platelet-derived EVs compared to healthy controls (p < 0.0001). After 12 weeks, liraglutide significantly reduced total EVs (-57%), endothelial-EVs (-85%), and platelet-EVs (-55%) (all p < 0.002), independently of changes in HbA1c or body weight. All subjects completed the study treatment. No significant EV changes were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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