Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients
Condition: Non-Alcoholic Fatty Liver Disease; Hyperuricemia
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hyperuricemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Metabolic associated fatty liver disease (MAFLD) is the most common and harmful chronic liver
      disease, and it is increasingly diagnosed in many developed and developing countries.

      Previous studies suggested a significant association between hyperuricemia and MAFLD and that
      hyperuricemia plays a causal role in the development of MAFLD.

      Xanthine oxidase is a key enzyme in uric acid metabolism, and It thus can be considered as is
      a therapeutic target for MAFLD, so long-term urate-lowering therapy may play a role in
      amelioration of MAFLD by controlling uric acid levels. So, this study is conducted to assess
      the effect of controlling hyperuricemia using different xanthine oxidase inhibitors on
      amelioration of MAFLD.
    

Detailed description: 
      The aim of this study is to evaluate the effect of urate lowering therapy on improvement of
      steatosis in metabolic associated fatty liver disease (MAFLD) patients with hyperuricemia, by
      comparing two xanthine oxidase inhibitors allopurinol (100 mg/day), versus Febuxostat (40
      mg/day), versus lifestyle intervention.

      Primary Outcome: Regression of hepatic steatosis. Secondary Outcome: Improvement of Serum
      uric acid and incidence of hepatotoxicity.

      Study design: This study is a prospective, interventional three arm study. Setting: Patients
      will be recruited from the National Hepatology and Tropical Medicine Research institute,
      Cairo, Egypt.
    

Intervention name(s): Allopurinol (100 mg/day) plus lifestyle intervention; Febuxostat 40 mg plus lifestyle intervention; Life style intervention
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): participants accept allopurinol treatment (100 mg, once a day, orally). Behavioral: lifestyle intervention According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).; participants accept Febuxostat treatment (100 mg, once a day, orally). Behavioral: lifestyle intervention According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).; According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).
Other intervention name(s): Allopurinol group; Febuxostat group
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 90 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 for 24 weeks, and the experimental group was given febuxostat oral therapy or allopurinol oral therapy on the basis of lifestyle intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fatty liver disease; Hyperuricemia; Allopurinol; Febuxostat