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The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | avandia |
|
| 2 | Experimental | avandia plus metformin |
|
| 3 | Experimental | avandia plus losartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avandia | Drug | 4 mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| liver biopsy histologic improvement | end of study |
| Measure | Description | Time Frame |
|---|---|---|
| serum transaminases | throughout study (ongoing) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M Torres, MD | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Recruiting | San Antonio | Texas | 78234 | United States |
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| metformin |
| Drug |
500 mg twice daily for 48 weeks |
|
| losartan | Drug | losartan 50 mg once daily |
|
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D008687 | Metformin |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D013777 | Tetrazoles |
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