Nonalcoholic fatty liver disease NAFLD
Conditions
Interventions
Patients with non-alcoholic fatty liver disease with hypertriglyceridemia and type 2 diabetes mellitus who are receiving treatment including SGLT2 inhibitor administration will be assigned to the stud
Sponsors
Otsuka Motoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 18 age old over 2 Regardless of gender 3 Patients with fatty liver on imaging (either US/CT/MRI) 4 Patients diagnosed with type 2 diabetes and controlled to HbA1c 150 mg/dL or anytime TG>175 mg/dL and fasting/anytime TG<500 mg/dL) 6 Patients with hepatic dysfunction (male: 42 U/L < ALT < 126 U/L, female: 28 U/L < ALT < 84 U/L) 7 Patienst or proxy who have been fully informed consent
Exclusion criteria
Exclusion criteria: 1 Patients with complications of other liver diseases such as active viral hepatitis, autoimmune hepatitis, primary cholestatic cholangitis, drug-induced liver injury 2 Alcohol consumption, 30 g/day or more (men) or 20 g/day or more (women) in terms of ethanol 3 Patients taking concomitantly prohibited drugs (see 4.6.2 Concurrently Prohibited Drugs (Therapy)) 4 Patients with liver cirrhosis of Child-Pugh Classification B or C 5 Patients with a history of Allergy to pemafibrate 6 Patients with gallstones or biliary obstruction 7 Patients scheduled to receive additional or changed hypoglycemic medications 8 Prior treatment with fibrates or SPPARM within 12 weeks of obtaining consent 9 Being pregnant or possibly pregnant 10 Patients who judged as inappropriate candidate by the chief medical examine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of those with normalized ALT (males: ALT <42 U/L, females: ALT <28 U/L) at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Percentage of those with normalized ALT (males: ALT <42 U/L, females: ALT <28 U/L) at 12 weeks 2 Amount and Percentage Change in Blood Test Values 3 Percent change in liver hardness (VCTE, MRE) 4 Change in fibrosis marker/index 5 Percent change in liver fat content (CAP, ATI) 6 Percentage change in liver fat percentage (MRI-PDFF) 7 Percent change in weight and BMI 8 Percentage of individuals with normalized ALT at 24 weeks between those taking a single SGLT2 inhibitor and those taking multiple concomitant hypoglycemic medications for the treatment of diabetes, as well as 1-7 ratings and comparisons between the two groups 9 Percentage of individuals with normalized ALT at 24 weeks by pemafibrate dose, as well as 1-7 ratings and comparisons between the two groups 10 Adverse Events and Side Effects | — |
Contacts
Public ContactYasuto Takeuchi
Okayama University Hospital
Outcome results
None listed