Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

Not yet recruiting

• Conditions: Hyperuricemia and MAFLD

• Registration Number: NCT07053709
• Lead Sponsor: Assiut University

Brief Summary

Due to the established correlation between serum uric acid (SUA) levels and metabolic associated fatty liver disease (MAFLD), this study aims to screen for hyperuricemia in all patients diagnosed with MAFLD.

The ultimate goal is to support the management of MAFLD and improve patients' quality of life by reducing both morbidity and mortality.

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) has become increasingly prevalent in recent years and is now considered a leading cause of chronic liver disease worldwide, representing a major global public health challenge.

This growing prevalence is largely attributed to changes in lifestyle and dietary habits, making NAFLD the most common chronic liver condition globally, with an estimated global prevalence of 30.1%.

Recently, an international expert consensus proposed redefining NAFLD as metabolic dysfunction-associated fatty liver disease (MAFLD) to better reflect the disease's underlying metabolic basis. The diagnosis of MAFLD is based on the presence of hepatic steatosis in more than 5% of hepatocytes, in the absence of excessive alcohol intake or other causes of chronic liver disease. The diagnosis also requires at least one of the following three criteria: (1) overweight or obesity, (2) type 2 diabetes mellitus, or (3) evidence of metabolic dysregulation. Metabolic dysregulation is defined by the presence of at least two of the following abnormalities: increased waist circumference, elevated blood pressure, dyslipidemia, prediabetes, insulin resistance, or elevated plasma C-reactive protein (CRP) levels.

"Burned-out" NAFLD has been suggested as a potential hidden cause of cryptogenic cirrhosis. Therefore, early detection and management of NAFLD and its metabolic risk factors are critical to prevent disease progression and hepatic failure.

Uric acid (UA) is the final product of purine metabolism in the liver, with xanthine oxidase (XO) catalyzing the conversion of hypoxanthine to xanthine and subsequently to UA.

Abnormal UA metabolism is associated with various systemic diseases, including hypertension, atherosclerosis, diabetes mellitus, and dyslipidemia.

In recent years, increased interest has been directed toward the relationship between serum uric acid (SUA) levels and NAFLD severity. SUA has been identified as an independent risk factor significantly correlated with NAFLD severity, regardless of other metabolic markers. Studies have shown a 21% increase in NAFLD risk for every 1 mg/dL rise in SUA, and hyperuricemia is associated with a higher risk of advanced liver fibrosis in NAFLD patients.

Given the strong association between SUA levels and NAFLD progression, SUA-lowering therapy has emerged as a potential strategy for improving liver outcomes. Xanthine oxidase inhibitors, such as febuxostat and allopurinol, are commonly used to reduce SUA levels and have shown promise in improving liver histology in patients with NAFLD

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-21
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults aged over 18 years.
• Diagnosis of MAFLD based on abdominal ultrasonography or other validated imaging techniques.

Exclusion Criteria

• Patients aged 18 years or younger.
• Pregnant individuals.
• Presence of any malignancy.
• Diagnosis of type 1 diabetes mellitus (T1DM).
• Patients with fatty liver disease who have previously undergone bariatric surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Search for hyperuricemia in every patient with MAFLD	At diagnosis and follow up after 6 month	1. Prevalence of Hyperuricemia in Patients with MAFLD Description:Number of participants diagnosed with hyperuricemia based on serum uric acid levels.Time Frame:At diagnosis and 6-month follow-up, Unit of Measure:Number of participants; 2. Mean Serum Uric Acid Level Description:Average serum uric acid concentration among study participants. Time Frame:At diagnosis and 6-month follow-up, Unit of Measure:mg/dL; 3. Alanine Aminotransferase (ALT) Level Description:Mean ALT level to assess liver function. Time Frame: At diagnosis and 6-month follow-up. Unit of Measure: IU/L; 4. Aspartate Aminotransferase (AST) Level Description:Mean AST level to assess liver function.Time Frame:At diagnosis and 6-month follow-upUnit of Measure:IU/L; 5. Alkaline Phosphatase (ALP) Level Description:Mean ALP level to assess liver function.Time Frame:At diagnosis and 6-month follow-up. Unit of Measure:IU/L; 6. Serum Albumin Level:Mean serum albumin concentration.Time Frame:At diagnosis and 6-month follow up.