jRCTs051220016已完成不适用
Effect of Luseogliflozin on myocardial flow reserve in patients with type 2 diabetes (Lucent-J Study)
未提供0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- myocardial microcirculatory reserve (MFR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 50age old over 至 No limit（—）
- 性别
- All
入选标准
- •Type 2 diabetic patients age 50 and over
- •Patients with HbA1c 8.5% or less (Most recent HbA1c within 13 weeks prior to consent)
- •Patients who received an ammonia PET examination before the date of consent acquisition, and MFR of 3.0 or less (Most recent MFR within 13 weeks prior to consent)
- •Patients with written consen
排除标准
- •Patients with heart disease (myocardial infarction, cardiomyopathy, atrial fibrillation, severe valvular disease)
- •Patients who underwent cardiac bypass surgery or catheter treatment for ischemic heart disease within 13 weeks prior to consent
- •Patients with coronary artery disease who are indicated for coronary revascularization, or patients with suspected coronary artery disease who are indicated for coronary angiography
- •Persons with severe renal dysfunction
- •Patients with severe hepatic dysfunction (ALT or AST is 5 times or more of the standard value)
- •Patients with a malignant tumor currently being treated or during palliative care
- •Patients participating in or planning to participate in intervention studies using other medicines or medical devices
- •Pregnant or lactating women
- •Patients with contraindications to luseogliflozin (hypersensitivity, severe ketosis, diabetic coma, severe infections, before or after surgery, serious trauma)
- •In the young old (65=<age<75) and latter-stage elderly (75=<age), it is a patient of the geriatric syndrome or BMI=<18
- •Patients who received SGLT2 inhibitors from 13 weeks before the ammonia PET examination to the date of consent acquisition
- •Patients who have newly started or changed or discontinued diabetes treatment drugs, nitroglycer in preparations, vasodilators, and antihypertensive drugs within 13 weeks before obtaining consent. However, temporary drug changes are allowed due to suspected ischemia on ammonia PET scans.
- •Patients whose participation in this study is deemed inappropriate by the investigator or co-investigator
结局指标
主要结局
myocardial microcirculatory reserve (MFR)
时间窗: 24 weeks after the start of administration
Differences between the groups in the amount of change
次要结局
- Change in weight, BMI, blood pressure, and laboratory parameters(4, 12, and 24 weeks)
- Difference in MFR change between high and low MFR groups
研究者
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