Improving fatty liver by SGLT-2 inhibitor (SESIFAL)

Completed

• Conditions: Type 2 diabetes mellitus with hepatic steatosis

• Registration Number: jRCTs031200093

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-24
• Study Start: 2021-08-27
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Change in proton density fat fraction (PDFF)	24 weeks after the intervention	as measured by MRI from baseline* to 24 weeks after the intervention; *before the intervention

Secondary Outcome Measures

Name	Time	Method
Change in liver stiffness as measured by Fibroscan and CAP	12 and 24 weeks	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
Change in body weight and body fat percentage	24 weeks	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
Change in liver stiffness as measured by MRI	24 weeks	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
Change in serum markers	4, 12 and 24 weeks	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