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临床试验/JPRN-UMIN000019192
JPRN-UMIN000019192已完成未知

Investigation of the Effect of Dapagliflozin on Body Composition and Diet in Japanese Patients with Type 2 Diabetes Mellitus - Dapagliflozin Intervention Trial (DIET)

Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University0 个研究点目标入组 60 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
60

研究概览

简要总结

As a result of treatment with dapagliflozin to 54 Japanese patients with type 2 diabetes for 2 years, body weight was significantly reduced, in addition to the improvement of blood glucose and blood pressure. This study suggested that most of the weight loss was due to the decreases in body fat mass and fatty liver.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 74years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1) Patients with type 1 diabetes mellitus or secondary diabetes. 2) Patients with infection, postoperative/preoperative status, or severe trauma. 3) Patients with a history of myocardial infarction, angina pectoris, stroke, cerebral infarction, or transient ischemic attacks (TIA). 4) Patients with diabetic retinopathy requiring photocoagulation or vitreous surgery or those who have undergone any of these operations within one year. 5) Patients with moderate or worse renal dysfunction (eGFR < 45mL/min/1.73m2). 6) Patients with severe hepatic dysfunction (Child-Pugh Class C) or liver cirrhosis. 7) Patients with moderate or severe cardiac failure (New York Heart Association Class III or IV). 8) Patients taking GLP-1 receptor agonists. 9) Pregnant or breast-feeding women, as well as women of childbearing potential or those who plan to become pregnant. 10) Patients with a history of hypersensitivity to the study drug. 11) Patients with severe ketosis, diabetic coma, or precoma. 12) Patients with pacemaker. 13) Other patients who are deemed to be inappropriate for the study by the attending physician.

研究者

发起方
Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University

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