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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally) | Experimental | participants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week. |
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| Control group: Lifestyle intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| febuxostat treatment | Drug | According to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally) |
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| Measure | Description | Time Frame |
|---|---|---|
| Liver fat content of subjects in different groups | Liver fat was assessed based on Magnetic Resonance Imaging (MRI). | at the first week. |
| Liver fat content of subjects in different groups | Liver fat was assessed based on Magnetic Resonance Imaging (MRI). | at the 24th week . |
| Liver fat content of subjects in different groups | Liver fat was assessed based on Magnetic Resonance Imaging (MRI). | at the 48th week. |
| 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 |
| 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. |
| 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. |
| Serum uric acid levels of subjects in different groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo first hospital | Ningbo | Zhejiang | 315000 | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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A total of 200 subjects are enrolled in this study. After the initial screening, the subjects were randomly divided into the control group and the drug treatment group. The control group was given lifestyle intervention at 0-24 weeks, and the experimental group was given febuxostat oral therapy on the basis of lifestyle intervention. If the results showed that the reduction of liver fat content of subjects in the lifestyle intervention combined with febuxostat treatment group was significantly better than that in the lifestyle intervention group alone, the original intervention was continued in the drug treatment group, and the control group was given febuxostat orally on the basis of the lifestyle intervention at 24-48 weeks.
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| lifestyle intervention | Behavioral | According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise). |
|
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. |
| 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. |
| 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. |