Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Fatty liver disease, Hyperuricemia, Allopurinol, Febuxostat Read More

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 other respiratory diseases.
  • Intestinal diseases such as inflammatory bowel disease.
  • Any history of systemic malignancy in the past 5 years.
  • Use of uric-lowering drugs in the 4 weeks before screening: febuxostat, allopurinol, benzbromarone.
  • Morbid obesity (BMI>37.5kg/m2).
  • Triglyceride ≥5.0 mmol/L was found to be significantly abnormal in baseline examination.
  • had received systemic hormone or immunosuppressive therapy within 3 months prior to screening or expected to receive hormone or immunosuppressive therapy in the future.
  • Use of other drugs affecting uric acid metabolism were adjusted within 4 weeks before screening: losartan, fenofibrate, irbesartan, thiazide diuretics, loop medullar diuretics, compound antihypertensive agents containing diuretics.

Other drugs that may affect liver fat content were taken within 4 weeks before screening.

• Women who are lactating or pregnant.