Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.
Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.
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DOI：
10.1007/s13300-017-0292-1
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发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
UTOPIA study investigators
中科院分区：
文献类型：
--
作者：
Katakami N;Mita T;Yoshii H;Shiraiwa T;Yasuda T;Okada Y;Umayahara Y;Kaneto H;Osonoi T;Yamamoto T;Kuribayashi N;Maeda K;Yokoyama H;Kosugi K;Ohtoshi K;Hayashi I;Sumitani S;Tsugawa M;Ohashi M;Taki H;Nakamura T;Kawashima S;Sato Y;Watada H;Shimomura I;UTOPIA study investigators
钠-葡萄糖协同转运蛋白2（SGLT 2）抑制剂是一种抗糖尿病药物，可改善血糖控制，低血糖风险低，并改善各种心血管风险因素。本文所述的正在进行的研究的目的是使用颈动脉内膜中层厚度（IMT）（一种心血管疾病（CVD）的既定标志物）作为标志物，研究托福格列净（一种强效和选择性SGLT 2抑制剂）对2型糖尿病（T2 DM）受试者动脉粥样硬化进展的预防作用。使用Tofoglivaline可能更好地干预2型糖尿病患者动脉粥样硬化的研究（UTOPIA）试验是一项前瞻性、随机、开放标签、盲态终点、多中心和平行组比较研究。目的是在24家临床研究中心招募总计340例无明显CVD病史的T2 DM受试者，并将其随机分配至托福格列净治疗组或使用SGLT 2抑制剂以外药物的常规治疗组。作为主要结局，将通过颈动脉回波描记术测量104周治疗期间颈总动脉平均IMT和最大IMT的变化。次要结局包括血糖控制的变化、与β细胞功能和糖尿病肾病相关的参数、CVD和不良事件的发生以及反映血管功能的生化指标。这是首项在无CVD病史的T2 DM受试者中探讨SGLT 2抑制剂对颈动脉IMT进展的影响的研究。结果将在不久的将来公布，这些发现有望提供有助于预防糖尿病动脉粥样硬化和随后的CVD的临床数据。Kowa Co.，Ltd. UMIN 000017607.本文的在线版本（doi：10.1007/s13300-017-0292-1）包含补充材料，可供授权用户使用。
Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker. The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function. This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD. Kowa Co., Ltd. UMIN000017607. The online version of this article (doi:10.1007/s13300-017-0292-1) contains supplementary material, which is available to authorized users.
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影响因子：
2.4
作者：
Inzucchi SE;Zinman B;Wanner C;Ferrari R;Fitchett D;Hantel S;Espadero RM;Woerle HJ;Broedl UC;Johansen OE
通讯作者：
Johansen OE
影响因子：
16.2
作者：
Frier BM;Schernthaner G;Heller SR
通讯作者：
Heller SR
DOI：
10.7326/0003-4819-124-1_part_2-199601011-00009
发表时间：
1996-01-01
影响因子：
39.2
作者：
Laakso, M
通讯作者：
Laakso, M
DOI：
10.1152/ajpendo.00545.2012
发表时间：
2013-02-01
影响因子：
5.1
作者：
Nagata, Takumi;Fukazawa, Masanori;Kawabe, Yoshiki
通讯作者：
Kawabe, Yoshiki
影响因子：
158.5
作者：
Duckworth, William;Abraira, Carlos;Huang, Grant D.
通讯作者：
Huang, Grant D.