jRCTs031200093已完成不适用
A study of additional effect of SGLT-2 inhibitor in the improvement of fat accumulation in the liver (SESIFAL)
未提供0 个研究点目标入组 50 人开始时间: 2021年8月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change in proton density fat fraction (PDFF)
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
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Type 2 diabetes mellitus
- •Hepatic steatosis
- •Outpatients or inpatients
- •Meeting the following criteria with the tests results <=14 days before enrollment
- •(1) HbA1c >=6.5% and <=10%
- •(2) CAP >=250db/m
- •Aged >=20 years, =<75 years at consent
- •Written informed consent
排除标准
- •SGLT2 inhibitor taken within 1 year before consent
- •Pioglitazone taken within 1 year before consent
- •Viral hepatitis
- •Severe ketosis, diabetic coma or precoma
- •Severe infection, pre and post surgery, and severe injury
- •History of hypersensitivity to any of the ingredients of the study drug
- •Servere hepatic dysfunction
- •Severe renal dysfunction or patients requiring dialysis (including peritoneal dialysis)
- •Dehydration or pre-clinical dehydration
- •malnutrition, famine, debilitation, pituitary (gland) malfunction or adrenal gland dysfunction
- •Severe impairment of cardiovascular or lung function (such as shock, heart failure, cardiac infarct, pulmonary embolism) or patient tend to be hypoxia
- •Excessive alcohol intake
- •Diabetic ketoacidosis
- •History of lactic acidosis
- •Pregnant
- •Nursing
- •Female patient who is unable to take abstinence or effective contraceptive methods during this study
- •Contraindication to MRI
- •Judged ineligible by doctor in charge for other reasons
结局指标
主要结局
Change in proton density fat fraction (PDFF)
时间窗: 24 weeks after the intervention
as measured by MRI from baseline* to 24 weeks after the intervention *before the intervention
次要结局
- Change in liver stiffness as measured by Fibroscan and CAP(12 and 24 weeks)
- Change in body weight and body fat percentage(24 weeks)
- Change in liver stiffness as measured by MRI(24 weeks)
- Change in serum markers(4, 12 and 24 weeks)
研究者
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