| Trial ID: | L3065 |
| Source ID: | NCT05946148
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)
|
| Acronym: |
NAMELS-18
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease|Liver Steatosis
|
| Interventions: |
DRUG: Empagliflozin|DRUG: Dulaglutide|DRUG: Control Rx
|
| Outcome Measures: |
Primary: Liver Fat Fraction reduction, Change of Liver Fat Fraction as calculated by MRI-PDFF, 52 weeks|>30% Liver Fat Fraction reduction, Percentage of each group's participants that achieves \>30% Liver Fat Fraction reduction, 52 weeks | Secondary: HbA1c change, Evaluation of HbA1c change in each group, 52 weeks|Body Mass Index change, Evaluation of Body Mass Index change in each group, 52 weeks|Fatty Liver Index (FLI), Evaluation of FLI change in each group., 52 weeks|Fibrosis-4 Index (FIB-4), Evaluation of FIB-4 change in each group., 52 weeks|Aspartate Aminotransferase to Platelet ratio Index (APRI), Evaluation of APRI change in each group., 52 weeks|NAFLD Fibrosis Score (NFS), Evaluation of NFS change in each group., 52 weeks|Shearwave Elastography (SWE), Evaluation of SWE change in each group., 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: National and Kapodistrian University of Athens | Collaborators: Alexandra Hospital, Athens, Greece|Hippocration General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
78
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2018-06-01
|
| Completion Date: |
2021-05-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-07-14
|
| Locations: |
"Hippocration" General Hospital of Athens, Athens, Attiki, 11527, Greece
|
| URL: |
https://clinicaltrials.gov/show/NCT05946148
|
