MASLD with CKD without DM
Conditions
Interventions
arm A(control/nutritional guidance group): Nutritional guidance (every 12 weeks) for 24 weeks
arm B(nutritional guidance,DAPA dose group):Nutritional guidance (every 12 weeks) and DAPA treatment (10 m
Sponsors
Fujii Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have given informed consent to participate in this study 2)Age at the time of consent is at least 18 years old 3)CKD stage G3 diagnosed by blood test (eGFR greater than 30, and less than 60 mL/min/1.73 m^2) 4)Diagnosis of fatty liver by imaging or liver biopsy and MASLD with at least one of the five cardiometabolic risk factors 5)Fasting blood glucose less than 126 mg/dL and HbA1c less than 6.5%, and no previous history of treatment or diagnosis of diabetes. 6)ALT level of at least 43 U/L for males and 24 U/L for females within 91days before obtaining consent
Exclusion criteria
Exclusion criteria: 1) The patient is taking an SGLT2 inhibitor within 91 days prior to case enrollment. * SGLT2 inhibitors will not be withdrawn or discontinued for this study. 2) Patient who has type 1 diabetes mellitus, polycystic kidney disease, lupus nephritis, ANCA-related vasculitis, or severe ketosis. 3)Patients who received immunotherapy for primary or secondary renal disease within 6 months of enrollment. 4) Patients with New York Heart Association (NYHA) class IV congestive heart failure. 5) Patients with myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks of registration. 6) Patients who have undergone or will undergo coronary revascularization within 12 weeks of enrollment. 7) Patients suffering from a disease with a prognosis of less than 2 years. 8) Patients with a history of hypersensitivity to any component of DAPA. 9) Patients with severe infections, before or after surgery, or severe trauma. 10) Patients with complications of malignancy (patients who have undergone radical surgery or completed administration of anticancer agents may be enrolled). 11) Elderly patients who are unable to comply with fluid intake (prone to dehydration). 12) Patients with a history of urinary tract infection or genital infection. 13) Patients with pituitary insufficiency or adrenal insufficiency. 14) Patients who are scheduled to continue antihypertensive medications (e.g., Ca antagonists, ACE inhibitors, ARBs), dyslipidemia medications (e.g., statins, ezetinib, fibrates), hyperuricemia medications, or diuretics taken prior to case enrollment, with a change in dosage and administration. 15) Is lactating or is pregnant or may become pregnant. 16) Has psychosis, drug addiction or narcotic addiction that would affect compliance with the research protocol. 17) Is otherwise deemed by the principal investigator or a subinvestigator to be an inappropriate subject for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ALT level at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of change in the following; CAP(FibroScan),LS(FibroScan),FIB-4 index,FLI,body weight,BMI,girth of the abdomen,Body Fat Content and Body Fat Percentage,Body Skeletal Muscle Mass and Body Skeletal Muscle Percentage,SMI(Skeletal Muscle mass Index),HOMA-IR,eGFR,urinary NAG,urinary protein creatinine ratio,AST,ALT,GGT,glucose,HbA1c,Type 4 collagen 7s,triglycerides,HDL-Cho,Non-HDL-Cho,Hemoglobin, hematocrit, urinary albumin | — |
Contacts
Public ContactHideki Fujii
Graduate School of Human Life and Ecology Osaka Metropolitan University
Outcome results
None listed