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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

Effects of Febuxostat for Interventions of Lowering Uric Acid in Patients With Gout With Nonalcoholic Fatty Liver Disease: a Multicenter, Open-label, Randomized, Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04772352
• Other study ID #: SUANAFLD V1.0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2021
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

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

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

Locations

Country	Name	City	State
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat content of subjects in different groups	Liver fat was assessed based on Magnetic Resonance Imaging (MRI).	at the first week.
Primary	Liver fat content of subjects in different groups	Liver fat was assessed based on Magnetic Resonance Imaging (MRI).	at the 24th week .
Primary	Liver fat content of subjects in different groups	Liver fat was assessed based on Magnetic Resonance Imaging (MRI).	at the 48th week.
Primary	Serum uric acid levels of subjects in different groups	blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.	at the first week
Primary	Serum uric acid levels of subjects in different groups	blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.	at the forth week.
Primary	Serum uric acid levels of subjects in different groups	blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.	at the twelfth week.
Primary	Serum uric acid levels of subjects in different groups	blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.	at the 24th week.
Primary	Serum uric acid levels of subjects in different groups	blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.	at the 36th week.
Primary	Serum uric acid levels of subjects in different groups	blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.	at the 48th week.