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Evaluation of allopurinol efficacy in patients with nonalcoholic fatty liver disease

Phase 3
Conditions
nonalcoholic fatty liver disease.
Fatty (change of) liver, not elsewhere classified
Registration Number
IRCT20160920029889N1
Lead Sponsor
Oroumia University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
44
Inclusion Criteria

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

Exclusion Criteria

Pregnancy and lactation
Use of drugs interact with allopurinol (including didanosine, angiotensin-converting enzyme inhibitors, antacids (except sodium bicarbonate), azathioprine, mercaptopurine, vitamin K antagonists (including warfarin and other coumarin derivatives))
Taking hepatotoxic drugs (including calcium channel blockers, high doses of synthetic estrogens, methotrexate, amiodarone, chloroquine)
Occurrence of allergic reaction due to allopurinol intake

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in liver steatosis. Timepoint: before the intervention and at the end of the study. Method of measurement: abdominal computed tomography scans-no contrast injection-spiral (liver hounsfield unit and the liver attenuation index (liver hounsfield unit minus spleen hounsfield unit)).;Change in systemic inflammation. Timepoint: before the intervention and at the end of the study. Method of measurement: high sensitivity c-reactive protein.
Secondary Outcome Measures
NameTimeMethod
Change in insulin resistance. Timepoint: before the intervention and at the end of the study. Method of measurement: homeostasis model assessment of insulin resistance.;Change in oxidative stress. Timepoint: before the intervention and at the end of the study. Method of measurement: malondialdehyde.;Change in lipid profile. Timepoint: before the intervention and at the end of the study. Method of measurement: triglycerides, total cholesterol, high density lipoprotein, low density lipoprotein.;Change in liver enzymes. Timepoint: before the intervention and at the end of the study. Method of measurement: alanine aminotransferase, aspartate aminotransferase.;Change in anthropometric measurements. Timepoint: before the intervention and at the end of the study. Method of measurement: weight, body mass index, waist circumference, hip circumference, waist to hip ratio.
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