Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Metabolic Dysfunction-Associated Steatotic Liver Disease in Patients With Type 2 Diabetes
Abstract
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.
Primary outcome: Change in liver fat fraction (%) measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver.
Enrollment: 51 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 51 participants or records.
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