| Trial ID: | L0059 |
| Source ID: | NCT03434613
|
| Associated Drug: |
Rosuvastatin
|
| Title: |
Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease|Dyslipidemias
|
| Interventions: |
Drug: Rosuvastatin|Drug: Rosuvastatin/ezetimibe combination
|
| Outcome Measures: |
liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments|Liver fibrosis measured by MRE(magnetic resonance elastography)|Change in hepatic steatosis index - controlled attenuation parameter (CAP)|Change in hepatic fibrosis index - liver stiffness measurement (LSM) measured by transient liver elastography (Fibroscan??; Echosens, Paris, France)|Changes in body weight (kg) before and after the administration of rosuvastatin with/without ezetimibe|Changes in waist circumference (cm) before and after the administration of rosuvastatin with/without ezetimibe|Changes in systolic & diastolic blood pressure (mmHg) before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of insulin (??U/mL), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of fasting glucose (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of HbA1c (percent), before and after the administration of rosuvastatin with/without ezetimibe|Change in insulin sensitivity determined by homeostatic model assessment insulin resistance (HOMA-IR) and beta cell function determined by HOMA-beta|Changes in serum concentrations of free fatty acid (??Eq/L), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of platelet (??103/ ??L), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of alkaline phosphate (U/L) and gamma-GT(U/L), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of total bilirubin (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol (mg/dL)), before and after the administration of rosuvastatin with/without ezetimibe|Changes in serum concentrations of CRP (mg/dL), before and after the administration of rosuvastatin with/without ezetimibe|Changes in the level of liver injury markers including IL-1beta, IL-8, IL-18 (pg/mL) before and after the administration of rosuvastatin with/without ezetimibe|Changes in plasminogen activator inhibitor-1 (ng/mL) in peripheral blood mononuclear cells, before and after the administration of rosuvastatin with/without ezetimibe|Changes in BMI (kg/m^2) before and after the administration of rosuvastatin with/without ezetimibe
|
| Sponsor/Collaborators: |
Yonsei University
|
| Gender: |
All
|
| Age: |
19 Years to 80 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
64
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
May 14, 2018
|
| Completion Date: |
September 11, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
July 9, 2021
|
| Locations: |
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center, Seoul, Korea, Republic of
|
| URL: |
https://ClinicalTrials.gov/show/NCT03434613
|
