| Trial ID: | L0062 |
| Source ID: | NCT03867487
|
| Associated Drug: |
Empagliflozin
|
| Title: |
SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Active, not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease|NAFLD|Pediatric NAFLD
|
| Interventions: |
Drug: Empagliflozin 10 MG|Drug: Placebo Oral Tablet
|
| Outcome Measures: |
Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)|Change in Body Measurements: Body mass index (BMI)|Change in Body Measurements: Body Fat %|Change in Body Measurements: Visceral Fat %|Change in Biomarkers of NAFLD: Alanine transaminase (ALT)|Change in Biomarkers of NAFLD: Cytokeratin (CK)-18|Change in Blood Pressure|Change in Arterial Stiffness|Change in Glycemic Control|Change in Proton Density Fat Fraction (PDFF) from MRI
|
| Sponsor/Collaborators: |
University of Minnesota
|
| Gender: |
All
|
| Age: |
12 Years to 17 Years ?? (Child)
|
| Phases: |
Phase 2
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
May 1, 2019
|
| Completion Date: |
December 1, 2024
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 4, 2022
|
| Locations: |
University of Minnesota, Minneapolis, Minnesota, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03867487
|
