Antidiabetic Drugs for Steatotic Liver Disease

Yonsei University51 enrolled

Overview

To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on metabolic dysfunction-associated steatotic liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy in patients with type 2 diabetes and steatotic liver disease will be compared and analyzed. This study was designed to include a total of 60 patients (20 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials. The drug will be maintained for a total of 24 weeks. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver between three groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Type 2 Diabetes Digestive System Disease

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and women aged 19 to 75 years 2. Individuals who are diagnosed with type 2 diabetes (HbA1c ≥ 7.5% and \< 11.0%) and treated with antidiabetic drugs excluding TZD and SGLT2i over the previous 12 weeks 3. Individuals diagnosed with steatotic liver disease as documented by abdominal ultrasonography within the previous year 4. Individuals who have voluntarily agreed in written form to participate in the clinical trial after hearing the explanation of this clinical trial 5. Individuals who understand the content of the clinical trial and are able to participate in the trial until the end of the clinical trial Exclusion Criteria: 1. Type 1 diabetes and gestational diabetes 2. Highly uncontrolled diabetes (HbA1c ≥ 11.0%) 3. Excessive alcohol intake (210 g and 140 g/week for men and women, respectively) within the previous 2 years 4. A history of taking thiazolidinedione or sodium-glucose cotransporter 2 inhibitor class medications within the last 12 weeks, or a history of discontinuing these medications due to severe side effects 5. Treatment with four or more classes of antidiabetic medications 6. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, within 24 weeks 7. Intake of drugs that can cause steatotic liver disease (amiodarone, methotrexate, tamoxifen, valproate, etc.) 8. Allergy or hypersensitivity to the study drugs or their constituents 9. Oral or parenteral chronic corticosteroid therapy (more than 14 consecutive days) that requires continual adjustments in corticosteroid dose for therapeutic purposes within 8 weeks 10. Galactosemia 11. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 12. Malignant tumors currently undergoing treatment or progression 13. A history of substance abuse or alcohol intoxication within 12 weeks 14. Infection of human immunodeficiency virus 15. Severe infection 16. Pre- and post-operative status, or severe trauma 17. Cardiac failure within 24 weeks (class III to IV in the NYHA classification) 18. Acute cardiovascular event within 12 weeks (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention) 19. AAcute and chronic renal disease (estimated glomerular filtration rate \< 45 mL/min/1.73 m²) or dialysis 20. Pregnant or lactating women 21. Individuals whom the investigator determines to be unsuitable for participation in the clinical trial

Outcomes

Primary Outcomes

Change in liver fat fraction (%) measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver

To measure the fat fraction, we drew the largest possible polygonal region of interest encompassing both lobes of the liver on a cross-sectional image, while avoiding blood vessels, bile ducts, and distinct hepatic lesions.