JPRN-jRCTs051200047已完成未知
Effects of canagliflozin, SGLT2 inhibitor, on renal oxygenation evaluated by blood oxygenation level-dependent (BOLD) MRI in patients with type 2 diabetes: An open-label, single-arm trial - Diamond study-8
Mori Katsuhito0 个研究点目标入组 14 人开始时间: 2020年8月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
Although results obtained in recent large clinical trials suggest protective effects of SGLT2 inhibitors on the kidneys, the precise mechanisms are largely unknown. We speculated that use of an SGLT2 inhibitor improves renal oxygenation. Thus, the effect of canagliflozin on renal oxygenation was examined using BOLD MRI. The findings indicate that canagliflozin may improve renal cortical oxygenation in patients with T2D.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1) Type 2 diabetes
- •2) Signed consent form
- •3) Age >= 20 years and < 80 years
- •4) HbA1c level >= 6.5% and < 10%
- •5) Patients without any SGLT2 inhibitors at least 2 weeks before first BOLD MRI (at least 17 days before first canagliflozin administration)
排除标准
- •1) Pregnancy or breat-feeding and its possibility
- •2) Known allergy to canagliflozin
- •3) Contraindication for MRI (pacemaker or claustrophobia)
- •4) Past history of recurrent urinary tract or genital infections
- •5) Nephrotic sydrome
- •6) Diuretics or NSAIDs
- •7) Severe renal dysfuntion (eGFR < 30 mL/min/1.73m2) or end-stage renal disease (dialysis) or renal transplantation
- •8) Renal morphological abnormality such as several cysts, hydronephrosis and abnormal calcification etc.
- •9) Severe hepatic dysfunction (AST or ALT > triple upper limit of facility criterion)
- •10) Malignant tumors
- •11) Severe heart failure (NYHA class III or IV)
- •12) Patients who participate in any clinical trial except this trial
- •13) Patients whom principal investigator judges as inappropriate for the trial
研究者
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