Hyperuricemia and MAFLDSUMANCT07053709
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
An observational study of Hyperuricemia and MAFLD, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperuricemia and MAFLD
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with metabolic-associated fatty liver disease (MAFLD) were enrolled. Data collected included demographics, clinical history (comorbidities such as diabetes, hyperlipidemia, and hypertension), lifestyle factors (including alcohol intake), anthropometric measures (BMI, waist circumference), blood tests (uric acid, liver enzymes, lipid profile, CBC, HbA1c, hs-CRP, viral markers), and imaging by transient elastography (FibroScan with CAP).
Who may be able to join
- Adults aged over 18 years.
- Diagnosis of MAFLD based on abdominal ultrasonography or other validated imaging techniques.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Medical subject headings
- Hyperuricemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Search for hyperuricemia in every patient with MAFLD
- 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
- 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
- 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
- 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
- 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
- Serum Albumin Level:Mean serum albumin concentration.Time Frame:At diagnosis and 6-month follow up.
Measured: At diagnosis and follow up after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 May 2025
- Primary completion1 Jun 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia and MAFLDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
- Investigators
- Assiut University, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053709
- Sponsor's protocol ID
- 4-2025-300626
- Acronym
- SUMA
- Status last verified
- Nov 2026
- First submitted
- 21 Jun 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
- ClinicalTrials.gov ID
- NCT07053709
- Acronym / sponsor ID
- SUMA / 4-2025-300626
- Conditions
- Hyperuricemia and MAFLD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with metabolic-associated fatty liver disease (MAFLD) were enrolled. Data collected included demographics, clinical history (comorbidities such as diabetes, hyperlipidemia, and hypertension), lifestyle factors (including alcohol intake), anthropometric measures (BMI, waist circumference), blood tests (uric acid, liver enzymes, lipid profile, CBC, HbA1c, hs-CRP, viral markers), and imaging by transient elastography (FibroScan with CAP).
Key inclusion criteria (2 listed)
- Adults aged over 18 years.
- Diagnosis of MAFLD based on abdominal ultrasonography or other validated imaging techniques.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Search for hyperuricemia in every patient with MAFLD
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assiut University principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia and MAFLD, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Search for hyperuricemia in every patient with MAFLD (time frame: At diagnosis and follow up after 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.