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Study aim
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Evaluation of the effect of allopurinol on liver steatosis, insulin resistance, systemic inflammation, oxidative stress, lipid profile, liver enzymes and anthropometric measurements in patients with non-alcoholic fatty liver disease compared to placebo
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Design
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In this phase III clinical trial, 44 eligible patients are enrolled. patients are randomly assigned in a 1 to 1 ratio to allopurinol or placebo groups. Randomization is performed online based on the blocked randomization method. The person who dose not play a role in checking in the inclusion criteria and intervention, assigns subjects to the groups according to the created codes.
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Settings and conduct
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This study is done on eligible patients with nonalcoholic fatty liver disease referred to the gastroenterology clinic. After obtaining informed consent, patients are invited for laboratory tests, computed tomography and anthropometric measurements. Patients are also requested to complete forms related to 24-hour dietary recall and physical activity. Patients are randomly assigned to either allopurinol or placebo groups. The person who does not play a role in intervention and is unaware of the allocation of patients , packs medications based on the created codes online. Then the medications are delivered to patients according to these codes. This randomization and assignment remain hidden from researchers and participants, until the completion of statistical analysis. After completing the 4-month intervention period, patients are invited to carry out assessed variables at the beginning of the study.
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Participants/Inclusion and exclusion criteria
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Entry requirements: age between 18 and 70 years; not having history of alcohol consumption; lack of other liver diseases; the levels of aminotransferases should not exceed 2.5 times the upper limit of normal; no previous allergy to allopurinol; not having chronic kidney disease (definedas an estimated glomerular filtration rate <60 mL/min/1.73m2); serum uric acid levels greater than 4 mg/dl for men and more than 3 mg/dl for women; for diabetic patients, hemoglobin A1c should be less than 8% and the dose of antidiabetic drugs should be constant for at least 3 months; not having hematological disorders; not having kidney stones.
Conditions of failure to enter: pregnancy and lactation; use of drugs interact with allopurinol; taking hepatotoxic drugs; occurrence of allergic reaction due to allopurinol intake.
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Intervention groups
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Intervention group: Allopurinol 300 mg once daily for 4 months.
Control group: Placebo once a day for 4 months.
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Main outcome variables
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In this study, the efficacy of allopurinol on the improving liver steatosis (assessed by computed tomography), insulin resistance (assessed by the homeostasis model), systemic inflammation, oxidative stress, lipid profile, liver enzymes and anthropometric measurements in patients with non-alcoholic fatty liver disease compared to placebo, is determined.