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

NCT ID: NCT04772352

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-01

Brief 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.

Detailed Description

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. In a large cross-sectional study, the researcher were the first to confirm that serum uric acid level was significantly increased in patients with NAFLD. The results were published in J Hepatol. 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.

Conditions

Nonalcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)

participants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week.

Group Type: EXPERIMENTAL

febuxostat treatment

Intervention Type: DRUG

According to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally)

lifestyle intervention

Intervention Type: BEHAVIORAL

According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).

Control group: Lifestyle intervention

participants receive lifestyle intervention for 0-24 week. If the results of the 0-24 week study showed that the liver fat content of subjects in the experimental group was significantly lower than that in the control group, control group will accept febuxostat treatment in addition to lifestyle intervention in the next 25-48 week.

Group Type: ACTIVE_COMPARATOR

lifestyle intervention

Intervention Type: BEHAVIORAL

According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).

Interventions

febuxostat treatment

According to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally)

Intervention Type: DRUG

lifestyle intervention

According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo first hospital

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

SUANAFLD V1.0

Identifier Type: -

Identifier Source: org_study_id