Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus: A randomized, open-label pilot study (ToPiND study)
Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus: A randomized, open-label pilot study (ToPiND study)
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DOI：
10.1016/j.conctc.2019.100516
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发表时间：
2020-03-01
影响因子：
1.5
通讯作者：
Nakajima, Atsushi
中科院分区：
文献类型：
--
作者：
Ozaki, Anna;Yoneda, Masato;Nakajima, Atsushi
背景：非酒精性脂肪性肝病(NAFLD)的发病率最近有所增加，这与肥胖以及2型糖尿病(DM)和代谢综合征诊断的相关激增有关。我们的目的是比较托福列津和吡格列酮对2型糖尿病合并NAFLD患者肝脏脂肪变性的治疗效果。方法：这是一项开放、前瞻性、随机的探索性研究。符合纳入标准但不符合任何排除标准的患者将接受基于磁共振成像(MRI)的质子密度脂肪分数(MRI-PDFF)。在MRI-PDFF中肝脏脂肪含量为10%的患者将被随机分配到托格列酮20 mg/d(n=20)或吡格列酮15-30 mg/d(n=20)。核磁共振成像将在药物治疗开始后24周进行。然后，两组患者将联合服用托福利嗪和吡格列酮，为期24周。48周时(联合用药后24周)再次行MRI检查。结果：我们研究的主要终点是用药后24周MRI-PDFF测量的肝脏脂肪变性的改变。次要终点是用药24周时丙氨酸氨基转移酶的变化，主要探索性终点是用药48周时肝脏脂肪含量的变化和肝硬化。结论：我们将通过MRI比较托福列津和吡格列酮治疗NAFLD合并DM患者肝脏脂肪变性的疗效，并探讨两种药物联合治疗NAFLD是否有效。
Background: The incidence of nonalcoholic fatty liver disease (NAFLD) has increased recently and is related to obesity and the associated surge in type 2 diabetes mellitus (DM) and metabolic syndrome diagnoses. We aim to compare the effectiveness of tofogliflozin and pioglitazone treatment on hepatic steatosis in patients with NAFLD with type 2 DM.Methods: This is an open label, prospective, randomized exploratory study. Patients who meet the inclusion criteria and do not meet any exclusion criteria will undergo magnetic resonance imaging (MRI)-based proton density fat fraction (MRI-PDFF). Patients with >= 10% liver fat content on MRI-PDFF will be randomly assigned to receive tofogliflozin 20 mg per day (n = 20) or pioglitazone 15-30 mg per day (n = 20). MRI will be performed after 24 weeks following initiation of medication therapy. Then, patients will take tofogliflozin and pioglitazone in combination in both groups for 24 weeks. MRI will be performed again at 48 weeks (24 weeks after initiation medication in combination).Results: Our study's primary endpoint will be change in hepatic steatosis measured by MRI-PDFF at 24 weeks after medication therapy. The secondary endpoint will be change in alanine aminotransferase at 24 weeks of medication therapy and the main exploratory endpoint will be changes in liver fat content and liver sclerosis at 48 weeks of medication.Conclusions: We will compare the effectiveness of tofogliflozin and pioglitazone treatment using MRI for improving hepatic steatosis in patients with NAFLD complicated by DM and investigate if the combination of these two medications is effective for treating NAFLD.