PDF(Pubmed)
Abstract：
BACKGROUND: Arteriosclerosis and non-alcoholic fatty liver disease are major complications of diabetes mellitus. Hyperglycemia, insulin resistance, obesity, and metabolic syndrome are associated with the progression of these complications. Sodium-glucose transporter 2 inhibitors such as luseogliflozin are oral hypoglycemic agents that reduce glucose levels, induce loss of weight or body fat, and improve liver function. However, the effects of these agents on lipid profiles are unclear. Therefore, this study aimed to investigate these effects and their relationship with arteriosclerosis and non-alcoholic fatty liver disease.
METHODS: This single-center, single-arm, open-labeled prospective study enrolled 25 outpatients with type 2 diabetes mellitus who visited Minami Osaka Hospital. Laboratory tests and body measurements were performed at weeks 0 and 24. Luseogliflozin was started at 2.5 mg/day after breakfast, and data from weeks 0 and 24 were evaluated. There were no changes in the doses of other antidiabetic and dyslipidemia drugs a month prior to or during the study.
RESULTS: The patients showed significant reductions in the levels of triglycerides, remnant-like particle cholesterol, and triglyceride/high-density lipoprotein cholesterol ratio, along with significant increases in the levels of high-density lipoprotein cholesterol and apolipoprotein A-1. Alanine aminotransferase, γ-glutamyl transpeptidase, and the fatty liver index were significantly reduced.
CONCLUSIONS: Luseogliflozin-induced changes in the lipid profile were related to the suppression or improvement of arteriosclerosis and liver function, respectively. Patients who received this drug also showed improvements in the levels of liver enzymes and reductions in the fatty liver index. Earlier use of luseogliflozin might prevent diabetic complications. Trial registration This study was registered in the University Hospital Medical Information Network Clinical Trial Registry (UMIN 000043595) on April 6th, 2021.
METHODS: This single-center, single-arm, open-labeled prospective study enrolled 25 outpatients with type 2 diabetes mellitus who visited Minami Osaka Hospital. Laboratory tests and body measurements were performed at weeks 0 and 24. Luseogliflozin was started at 2.5 mg/day after breakfast, and data from weeks 0 and 24 were evaluated. There were no changes in the doses of other antidiabetic and dyslipidemia drugs a month prior to or during the study.
RESULTS: The patients showed significant reductions in the levels of triglycerides, remnant-like particle cholesterol, and triglyceride/high-density lipoprotein cholesterol ratio, along with significant increases in the levels of high-density lipoprotein cholesterol and apolipoprotein A-1. Alanine aminotransferase, γ-glutamyl transpeptidase, and the fatty liver index were significantly reduced.
CONCLUSIONS: Luseogliflozin-induced changes in the lipid profile were related to the suppression or improvement of arteriosclerosis and liver function, respectively. Patients who received this drug also showed improvements in the levels of liver enzymes and reductions in the fatty liver index. Earlier use of luseogliflozin might prevent diabetic complications. Trial registration This study was registered in the University Hospital Medical Information Network Clinical Trial Registry (UMIN 000043595) on April 6th, 2021.
摘要：
背景：动脉硬化和非酒精性脂肪性肝病是糖尿病的主要并发症。高血糖症,胰岛素抵抗，肥胖，代谢综合征与这些并发症的进展有关.钠-葡萄糖转运蛋白2抑制剂如卢索格列净是降低葡萄糖水平的口服降血糖药，导致体重减轻或身体脂肪减少，改善肝功能.然而,这些药物对血脂的影响尚不清楚.因此,本研究旨在探讨这些作用及其与动脉硬化和非酒精性脂肪性肝病的关系。
方法：这种单中心，单臂,开放标记的前瞻性研究纳入了25例2型糖尿病门诊患者,这些患者在大阪南上医院就诊.在第0周和第24周进行实验室测试和身体测量。Luseogliflozin在早餐后2.5毫克/天开始，评估第0周和第24周的数据。在研究前一个月或研究期间，其他抗糖尿病和血脂异常药物的剂量没有变化。
结果：患者显示甘油三酯水平显著降低，残余样颗粒胆固醇，和甘油三酯/高密度脂蛋白胆固醇的比例，随着高密度脂蛋白胆固醇和载脂蛋白A-1水平的显着增加。丙氨酸转氨酶,γ-谷氨酰转肽酶,脂肪肝指数显著降低。
结论：Luseogliflozin诱导的血脂变化与动脉硬化和肝功能的抑制或改善有关，分别。接受这种药物的患者也显示出肝酶水平的改善和脂肪肝指数的降低。早期使用luseogliflozin可能会预防糖尿病并发症。试验注册本研究于4月6日在大学医院医学信息网络临床试验注册中心（UMIN000043595）注册，2021年。
方法：这种单中心，单臂,开放标记的前瞻性研究纳入了25例2型糖尿病门诊患者,这些患者在大阪南上医院就诊.在第0周和第24周进行实验室测试和身体测量。Luseogliflozin在早餐后2.5毫克/天开始，评估第0周和第24周的数据。在研究前一个月或研究期间，其他抗糖尿病和血脂异常药物的剂量没有变化。
结果：患者显示甘油三酯水平显著降低，残余样颗粒胆固醇，和甘油三酯/高密度脂蛋白胆固醇的比例，随着高密度脂蛋白胆固醇和载脂蛋白A-1水平的显着增加。丙氨酸转氨酶,γ-谷氨酰转肽酶,脂肪肝指数显著降低。
结论：Luseogliflozin诱导的血脂变化与动脉硬化和肝功能的抑制或改善有关，分别。接受这种药物的患者也显示出肝酶水平的改善和脂肪肝指数的降低。早期使用luseogliflozin可能会预防糖尿病并发症。试验注册本研究于4月6日在大学医院医学信息网络临床试验注册中心（UMIN000043595）注册，2021年。
