Antidiabetic Drugs for Steatotic Liver Disease

Sponsor
Yonsei University
Study ID
NCT03646292
Phase
PHASE4
Status
Completed

Conditions

  • Digestive System Disease
  • Empagliflozin
  • Fatty Liver
  • Hypoglycemic Agents
  • Liver Diseases
  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Molecular Mechanisms of Pharmacological Action
  • Non-Alcoholic Fatty Liver Disease
  • Physiological Effects of Drugs
  • Pioglitazone
  • Sodium-Glucose Cotransporter 2 Inhibitors
  • Thiazolidinediones
  • Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone — DRUG
    The investigators will compare the degree of liver fat before and after pioglitazone monotherapy.
  • Empagliflozin — DRUG
    The investigators will compare the degree of liver fat before and after empagliflozin monotherapy.
  • Combination of pioglitazone and empagliflozin — DRUG
    The investigators will compare the degree of liver fat before and after pioglitazone and empagliflozin combination therapy.

Study Details

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.

Key Dates

Start date
Dec 6, 2018
Status verified
Mar 2025
Primary completion
Jun 16, 2022
Completion
Jun 16, 2022

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pioglitazone monotherapy
    Pioglitazone 15mg 1T daily for 24 weeks
  • Experimental: Empagliflozin monotherapy
    Empagliflozin 10mg 1T daily for 24 weeks
  • Experimental: Pioglitazone + Empagliflozin combination therapy
    Pioglitazone 15mg 1T + Empagliflozin 10mg 1T combination daily for 24 weeks

Primary Outcome Measure

Change in liver fat fraction (%) measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver [ Time Frame: After 24 weeks of treatment ]

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