A study of additional effect of SGLT-2 inhibitor in the improvement of fat accumulation in the liver - SESIFA

Tsuchiya Kyoichiro0 个研究点目标入组 1 人开始时间: 2020年8月24日最近更新: 2023年10月17日

适应症

试验速览

iver fat was decreased without any adverse events.

•1) Type 2 diabetes mellitus
•2) Hepatic steatosis
•3) Outpatients or inpatients
•4) Meeting the following criteria with the tests results <=14 days before enrollment
•(1) HbA1c >=6.5% and <=10%
•(2) CAP >=250db/m
•5) Aged >=20 years, =<75 years at consent
•6) Written informed consent

•1) SGLT2 inhibitor taken within 1 year before consent
•2) Pioglitazone taken within 1 year before consent
•3) Viral hepatitis
•4) Severe ketosis, diabetic coma or precoma
•5) Severe infection, pre and post surgery, and severe injury
•6) History of hypersensitivity to any of the ingredients of the study drug
•7) Servere hepatic dysfunction
•8) Severe renal dysfunction or patients requiring dialysis (including peritoneal dialysis)
•9) Dehydration or pre-clinical dehydration
•10) malnutrition, famine, debilitation, pituitary (gland) malfunction or adrenal gland dysfunction
•11) Severe impairment of cardiovascular or lung function (such as shock, heart failure, cardiac infarct, pulmonary embolism) or patient tend to be hypoxia
•12) Excessive alcohol intake
•13) Diabetic ketoacidosis
•14) History of lactic acidosis
•15) Pregnant
•16) Nursing
•17) Female patient who is unable to take abstinence or effective contraceptive methods during this study
•18) Contraindication to MRI
•19) Judged ineligible by doctor in charge for other reasons

发起方

Tsuchiya Kyoichiro