Effects of Febuxostat for Lowering Uric Acid in NAFLD Patients With Gout

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common and harmful chronic liver disease. NAFLD accounts for 49.3% of the total number of chronic liver disease patients in China. It is important to effectively prevent and control NAFLD and its related diseases.

Previous studies show the level of serum uric acid is significantly elevated in patients with NAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism. It is a new therapeutic target for NAFLD.

This study is aimed to further confirm that hyperuricemia is a new risk factor for NAFLD through a large sample prospective study. Furthermore, this study explore whether Xanthine oxidase (XO), a key enzyme in uric acid metabolism, plays an important role in regulating NAFLD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ningbo No. 1 Hospital
• Treatments: Febuxostat

Criteria

Inclusion Criteria:

• with informed consent;

• Ages 18-65;

• Overweight/obesity: BMI ≥24kg/m2;

• A history of gout with serum uric acid levels of > 420μmol/L in men and postmenopausal women, and >360 μmol/L in premenopausal women;

• Moderate or above fatty liver was found in the initial screening by ultrasound, and the liver fat content was more than 15% as determined by MRI-PDFF.

Exclusion Criteria:

• with 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);

• Patients with obvious abnormal liver function: serum transaminase (ALT, AST, GGT one of them) or serum bilirubin (direct bilirubin, indirect bilirubin one of them) exceed 2 times the upper limit of normal reference value; Serum albumin <35g/L;

• Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases;

• Complicated with renal insufficiency (SCr >133μmol/L) or urinary protein +;

• Complicated coronary heart disease;

• Cardiac dysfunction (cardiac function grade 2 or above);

• Complementation with diabetes, or fasting blood glucose >7.8mmol/L, or HbA1c >7.5%;

• Severe hypertension, blood pressure ≥ 160/100 mmHg;

• Patients with asthma and other respiratory diseases;

• Intestinal diseases such as inflammatory bowel disease;

• Any history of systemic malignancy in the past 5 years;

• 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 uric-lowering drugs in the 4 weeks before screening: febuxostat, benzobromarone, allopurinol;

• Use of other drugs affecting uric acid metabolism were adjusted within 4 weeks before screening: losartan, fenofibrate, irbesartan, thiazide diuretics, loop medullaral diuretics, compound antihypertensive agents containing diuretics;

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

• Weight change ≥5% within 3 months before screening;

• Women who are lactating or pregnant or who plan to become pregnant within one year;

• were enrolled in other studies within 6 months before screening;

• unsuitable for participants to participate in this study.