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The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis.
Does drug ABC Empagliflozin versus Statins as monotherapy and polytherapy improve the controlled attenuation parameter (CAP), the liver stiffness measurement (LSM), the proportion of patients with at least one point improvement or one-stage reduction in the histological scores with respect to hepatic steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis after treatment?
What medical problems do participants have when taking Empagliflozin versus Statins as monotherapy and polytherapy?
Participants will:
NAFLD is a growing global health problem linked with metabolic issues like obesity, diabetes, and insulin resistance. It ranges from simple liver fat accumulation to NASH, involving inflammation and liver damage, progressing to fibrosis, cirrhosis, and cancer. Managing NAFLD is tough due to diagnosis challenges and metabolic complications. Lifestyle changes like diet and exercise are key but often hard to sustain. No FDA-approved treatments exist yet, but drugs like Empagliflozin and statins are being studied for their potential to improve insulin sensitivity, reduce liver inflammation, and slow disease progression. This study compares these therapies for NAFLD and NASH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Active Comparator | 30 mg once daily orally for 3 months |
|
| Empagliflozin | Active Comparator | 10 mg once daily orally for 3 months |
|
| Statins | Active Comparator | Once daily orally for 3 months |
|
| Empagliflozin plus statins | Active Comparator | Once daily orally for 3 months |
|
| Pioglitazone plus Statins | Active Comparator | Once daily orally for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone (PIO) | Drug | 30 mg orally once daily |
| |
| Empagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| The controlled attenuation parameter (CAP). | The CAP value is expressed in dB/m. | After 3 months |
| The liver stiffness measurement (LSM) using FibroScan®. | The LSM value is expressed as kilopascal or kPa. | After 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrosis-4 (FIB-4) index | FIB-4 is a non-invasive scoring system that can predict significant hepatic fibrosis patients. | After 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman Swan, PHD | Contact | +201090111013 | eman.said@buc.edu.eg | |
| Raghda Hussien, PHD | Contact | +201010647666 | Raghda.hussien@pharm.bsu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Eman Swan | Badr University in Cairo, Faculty of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching hospital of Beni Suef University | Banī Suwayf | 62727 | Egypt |
Data is available with corresponding author on reasonable request
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| Drug |
10 mg orally once daily |
|
| Statin (Atorvastatin) | Drug | 20 mg orally once daily |
|
| Empagliflozin plus Statin (Atorvastatin) | Drug | Orally once daily of each (10 mg, 20 mg respectively) |
|
| Pioglitazone plus Atorvastatin | Drug | Orally once daily of each (30mg and 20mg respectively) |
|
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| C570240 | empagliflozin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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