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Antidiabetic Drugs for Steatotic Liver Disease

NCT03646292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-03-05

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Pioglitazone

The investigators will compare the degree of liver fat before and after pioglitazone monotherapy.

DRUG

Empagliflozin

The investigators will compare the degree of liver fat before and after empagliflozin monotherapy.

DRUG

Combination of pioglitazone and empagliflozin

The investigators will compare the degree of liver fat before and after pioglitazone and empagliflozin combination therapy.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2022-06-16
Completion
2022-06-16

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646292 on ClinicalTrials.gov