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

NCT ID: NCT07053709

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-11-01
• Study Completion Date: 2027-11-01

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

Conditions

Hyperuricemia and MAFLD

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mohammed Abdel Mowgod

Clinical lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assiut University

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Amira M Abdelmawgod, lecturer in Tropical Medicine, MD, Assuit University

Role: CONTACT

amiramohmad60@gmail.com

+201012760437

Other Identifiers

4-2025-300626

Identifier Type: -

Identifier Source: org_study_id