Effects of aerobic exercise on vascular endothelial function and markers of oxidative stress and inflammation in individuals with impaired glucose tolerance: study protocol for a randomized controlled trial

Background and objectiveEndothelial dysfunction is a key driver of cardiovascular complications in individuals with impaired glucose tolerance (IGT), with oxidative stress and inflammation playing pivotal roles in its pathogenesis. Although our previous studies have demonstrated that aerobic exercise (AE) significantly ameliorates IGT-induced endothelial dysfunction, the specific roles of oxidative stress and inflammation in this process remain to be elucidated. Therefore, we designed a randomized controlled trial to investigate the effects of AE on vascular endothelial function in patients with IGT and to further explore the underlying regulatory roles of oxidative stress and inflammation.MethodsSeventy individuals diagnosed with IGT will be enrolled in this two-arm, parallel-group randomized controlled trial, which utilizes an assessor-blinded design. Participants will be assigned in a 1:1 ratio to either a non-exercise control group or a 12-week supervised AE program, consisting of three weekly sessions at 65%–75% of their maximal heart rate. The primary endpoint will be the change in flow-mediated dilation (FMD) from baseline to week 12. Secondary endpoints will include cardiovascular function, glucose and lipid metabolism, circulating inflammatory and oxidative stress biomarkers, and ex vivo functional assays using participant-derived serum, including serum transfer experiments using human umbilical vein endothelial cells (HUVECs) and molecular profiling of endothelial progenitor cells (EPCs) cultured in the presence of the participants’ serum. Recruitment commenced in August 2025 and is currently ongoing.DiscussionThis study aims to investigate the impact of a 12-week moderate-intensity AE intervention on vascular endothelial function, oxidative stress, and inflammation levels in patients with IGT. We hypothesize that, compared with the non-exercise control group, 12 weeks of AE will significantly improve endothelial function and exert both systemic and endothelial-derived antioxidant and anti-inflammatory effects.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2500106827.