NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200093

Registered date:24/08/2020

Improving fatty liver by SGLT-2 inhibitor

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus with hepatic steatosis
Date of first enrollment27/08/2021
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Switching from DPP4 inhibitor/other drug to or adding Luseogliflozin versus switching from other drugs to DPP4 inhibitor or continuing of DPP4 inhibitor Arm 1: SGLT2 inhibitor (Luseogliflozin) Arm 2: DPP4 inhibitor

Outcome(s)

Primary OutcomeChange in proton density fat fraction (PDFF) as measured by MRI from baseline* to 24 weeks after the intervention Comparison of Arm 1 and Arm 2 *before the intervention
Secondary Outcome1) Change in liver stiffness as measured by MRI from baseline to 24 weeks after the intervention Comparison of Arm 1 and Arm 2 using t-test 2) Change in liver stiffness as measured by Fibroscan and CAP from baseline to 12 and 24 weeks after the intervention Comparison of Arm 1 and Arm 2 using t-test 3) Change in the following serum markers from baseline to 4, 12 and 24 weeks after the intervention; gamma-GTP, AST, ALT, TG, LDL-Chol, HDL- Chol, HbA1c, M2BPGI, Type 4 collagen7S, HMGB1 Comparison of Arm 1 and Arm 2 using t-test 4) Change in body weight and body fat percentage from baseline to 24 weeks after the intervention Comparison of Arm 1 and Arm 2 using t-test

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Kyoichiro Tsuchiya
Address 1110, Shimokato, Chuo-shi, Yamanashi Yamanashi Japan 409-3898
Telephone +81-55-273-9602
E-mail tsuchiyak@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital
Scientific contact
Name Kyoichiro Tsuchiya
Address 1110, Shimokato, Chuo-shi, Yamanashi Yamanashi Japan 409-3898
Telephone +81-55-273-9602
E-mail tsuchiyak@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital