Thirunavukarasu Sharmaine, Brown Louise Ae, Chowdhary Amrit, Jex Nicholas, Swoboda Peter, Greenwood John P, Plein Sven, Levelt Eylem
Multidisciplinary Cardiovascular Research Centre and Biomedical Imaging Science Department, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Diab Vasc Dis Res. 2021 May-Jun;18(3):14791641211021585. doi: 10.1177/14791641211021585.
Type 2 diabetes (T2D) is associated with an increased risk of cardiovascular (CV) disease. In patients with T2D and established CV disease, selective inhibitors of sodium-glucose cotransporter 2 (SGLT2) have been shown to decrease CV and all-cause mortality, and heart failure (HF) admissions. Utilising CV magnetic resonance imaging (CMR) and continuous glucose monitoring (CGM) by FreeStyle Libre Pro Sensor, we aim to explore the mechanisms of action which give Empagliflozin, an SGLT2 inhibitor, its beneficial CV effects and compare these to the effects of dipeptidyl peptidase-4 inhibitor Sitagliptin.
This is a single centre, open-label, cross-over trial conducted at the Leeds Teaching Hospitals NHS Trust. Participants are randomised for the order of treatment and receive 3 months therapy with Empagliflozin, and 3 months therapy with Sitagliptin sequentially. Twenty-eight eligible T2D patients with established ischaemic heart disease will be recruited. Patients undergo serial CMR scans on three visits.
The primary outcome measure is the myocardial perfusion reserve in remote myocardium. We hypothesise that Empaglifozin treatment is associated with improvements in myocardial blood flow and reductions in myocardial interstitial fibrosis, independent of CGM measured glycemic control in patients with T2D and established CV disease.
This study has full research ethics committee approval (REC: 18/YH/0190) and data collection is anticipated to finish in December 2021. This study was retrospectively registered at https://doi.org/10.1186/ISRCTN82391603 and monitored by the University of Leeds. The study results will be submitted for publication within 6 months of completion.
2型糖尿病（T2D）与心血管（CV）疾病风险增加相关。在患有T2D且已确诊CV疾病的患者中，钠-葡萄糖协同转运蛋白2（SGLT2）选择性抑制剂已显示可降低CV和全因死亡率以及心力衰竭（HF）住院率。利用CV磁共振成像（CMR）和FreeStyle Libre Pro传感器进行的连续血糖监测（CGM），我们旨在探索给予SGLT2抑制剂恩格列净有益CV效应的作用机制，并将其与二肽基肽酶-4抑制剂西他列汀的效应进行比较。
这是一项在利兹教学医院国民保健服务信托基金进行的单中心、开放标签、交叉试验。参与者被随机安排治疗顺序，并依次接受3个月的恩格列净治疗和3个月的西他列汀治疗。将招募28名符合条件的患有缺血性心脏病的T2D患者。患者在三次就诊时接受系列CMR扫描。
主要结局指标是远隔心肌的心肌灌注储备。我们假设，在患有T2D且已确诊CV疾病的患者中，恩格列净治疗与心肌血流改善和心肌间质纤维化减少相关，且独立于CGM测量的血糖控制情况。
本研究已获得完整的研究伦理委员会批准（REC：18/YH/0190），预计数据收集将于2021年12月完成。本研究已在https://doi.org/10.1186/ISRCTN82391603进行回顾性注册，并由利兹大学进行监测。研究结果将在完成后6个月内提交发表。
