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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Liver fat content of subjects in different groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)
participants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week.
干预措施: febuxostat treatment (Drug)
Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)
participants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week.
干预措施: lifestyle intervention (Behavioral)
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.
干预措施: lifestyle intervention (Behavioral)
结局指标
主要结局
Liver fat content of subjects in different groups
时间窗: at the 48th week.
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Serum uric acid levels of subjects in different groups
时间窗: at the 48th week.
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.
次要结局
未报告次要终点