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This randomized double blind clinical trial was performed in patients with non-alcoholic fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Liver function tests, metabolic profile and anthropometric measurements were checked at baseline and six months later.
This randomized double blind clinical trial was performed in patients with the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline + lifestyle modification | Experimental | Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity. |
|
| Lifestyle modification | Experimental | Obtaining ideal body weight by calorie restriction diet and programmed physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | Pentoxifylline 600 mg BD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline serum alanine aminotransferase at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline serum aspartate aminotransferase at 6 months | 6 months |
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Inclusion Criteria:
Patients with persistent elevated aminotransferase levels and the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raika Jamali, M.D. | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology clinic, Sina Hospital | Tehran | Tehran Province | Iran |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Lifestyle modification |
| Behavioral |
obtaining ideal body weight by calorie restriction diet and programmed physical activity. |
|
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |