CompletedPhase 4

Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients

Egypt90 participantsStarted 2022-01-01

Plain-language summary

Metabolic associated fatty liver disease (MAFLD) is the most common and harmful chronic liver disease, and it is increasingly diagnosed in many developed and developing countries. Previous studies suggested a significant association between hyperuricemia and MAFLD and that hyperuricemia plays a causal role in the development of MAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism, and It thus can be considered as is a therapeutic target for MAFLD, so long-term urate-lowering therapy may play a role in amelioration of MAFLD by controlling uric acid levels. So, this study is conducted to assess the effect of controlling hyperuricemia using different xanthine oxidase inhibitors on amelioration of MAFLD.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages 18-65. * Males and Females * Metabolic syndrome according to the NCEP ATP III definition \[13\]: present of three or more of the following five criteria are met: * Waist circumference over 40 inches (men) or 35 inches (women), Central obesity - defined as waist circumference ≥ 102 cm for Men and ≥ 88 cm for women * Blood pressure over 130/85 mmHg, * Basting triglyceride (TG) level over 150 mg/dl, * Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women), * Fasting blood sugar over 100 mg/dl. * Serum uric acid levels of \> 420μmol/L (\>7 mg/dL) in men and \>360 μmol/L (\>6 mg/dL) women. Exclusion Criteria: * Renal insufficiency defined by serum creatinine \> 2.0 mg/dl. * Patients with obvious abnormal liver function: serum transaminase (ALT, AST, one of them) exceed 2 times the upper limit of normal reference value. * Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases. * Complementation with diabetes, or fasting blood glucose \>7.8mmol/L, or HbA1c \>7.5%. * Severe hypertension, blood pressure ≥ 160/100 mmHg. * A history of allergy to febuxostat and allopurinol; in the acute active phase of gout. * Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female). * Complicated coronary heart disease. * Cardiac dysfunction (cardiac function grade 2 or above). * Patients with asthma and…

What they're measuring

Change in hepatic steatosis .

Timeframe: 3 months

Trial details

NCT IDNCT05474560

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-28