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Clinical Trial Details

Trial ID: L2456
Source ID: NCT05140694
Associated Drug: Empagliflozin
Title: Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Metabolic-associated Fatty Liver Disease|Type 2 Diabetes
Interventions: DRUG: Empagliflozin|DRUG: Dulaglutide|DRUG: Empagliflozin and Dulaglutide
Outcome Measures: Primary: Changes of HbA1c level, Patients achieving the target level, baseline, week 12, week 24|Changes of CAP score, Controlled Attenuation Parameter (CAP) score by transient elastography, baseline, week 24 | Secondary: Changes of LSM score, Liver stiffness measurement (LSM) score by transient elastography, baseline, week 24|Changes of noninvasive liver fibrosis markers, Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study, baseline, week 12, week 24|Changes of body weight and body composition, Body composition by bioelectrical impedance will be measured at baseline and at the end of the study, baseline, week 24|Changes of lipid levels, Cholesterol level will be measured at all visit days, baseline, week 12, week 24|Changes of ketone levels, Ketone level will be measured at all visit days, baseline, week 12, week 24|Changes of liver parenchyma by ultrasonography, improvement or deterioration, baseline, week 24|Changes of liver function parameters, Liver enzymes, albumin will be measured at all visit days., baseline, week 12, week 24|Changes of liver fibrosis biomarkers, Type IV collagen, baseline, week 24|Changes of inflammation biomarker, high-sensitivity CRP, baseline, week 24 | Other: Changes of urine markers, Urinalysis will be performed at all visit days, baseline, week 12, week 24|Changes of bone health, parathyroid hormone, 25-hydroxylated vitamin will be measured at all visit days, baseline, week 12, week 24|Changes of gut microbiota, gut microbiota composition, microbiota related to metabolic dysfunction, baseline, week 24
Sponsor/Collaborators: Sponsor: Seoul National University Bundang Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 135
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2022-10-04
Locations:
URL: https://clinicaltrials.gov/show/NCT05140694