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the study was stopped because of lack of interest
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The aim of the current study is to evaluate the association of fatty liver severity and endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the impact of statin treatment compared to usual care or life style modification on endothelial function, liver steatosis and fibrosis.
The study cohort will include 150 patients with fatty liver per ultrasound or histology. The patients will be divided randomly to one of three arms: follow up group, lifestyle modification group, and statins therapy (Atorvastatin 20mg/d for 6 months). at screening, after 6 months (end of treatment), and 12 months the patients will undergo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin | Active Comparator | statin therapy (atorvastatin 20 mg/d) for 6 months |
|
| usual care | No Intervention | follow up group with no intervention | |
| lifestyle counseling | Active Comparator | lifestyle modification by dietician counseling and follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | atorvastatin 20 mg per day for 6 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in liver steatosis at 6 months | Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver steatosis and fibrosis. Liver steatosis will be assessed by sonographic liver fat quantification (hepatorenal sonographic index. | baseline, 6 months and 12 months |
| change from baseline in liver fibrosis at 6 months | Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver fibrosis. Liver fibrosis will be assessed by Real-Time shear wave elastography. | baseline, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients | measurement of endothelial function in NAFLD patients and finding the correlation between the degree of endothelial dysfunction and the severity of fatty liver disease. Endothelial function will be assessed by brachial artery flow-mediated (FMD) measurement at diagnosis and after 6 and 12 months. The severity of fatty liver disease will be assessed by liver elastography and sonographic liver fat quantification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziv Ben-Ari, MD | Sheba Medical Center, Ramat Gan, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | 5265601 | Israel |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| lifestyle counseling | Behavioral | lifestyle modification by dietician counseling and follow up |
|
| 12 months |
| relationship between blood parameters and liver steatosis and fibrosis | levels of liver enzymes, liver synthetic function, blood lipids, insulin resistance, ferritin, adiponectin, C reactive protein, Tumor necrosis factor alpha and ceruloplasmin and their correlation with liver steatosis and fibrosis | 12 months |
| relationship between blood parameters and endothelial function | levels of liver enzymes, liver synthetic function, blood lipids, insulin resistance, ferritin, adiponectin, C reactive protein, tumor necrosis factor alpha and ceruloplasmin and their correlation with endothelial function | at diagnosis and after 6 months and 12 months |
| change from baseline in endothelial function at 6 months | Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on endothelial function. Endothelial function will be assessed by flow mediated dilatation (FMD) of brachial artery. | at diagnosis 6 months and 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |