HyperuricemiaNCT07168551
Is There a Relationship Between Uric Acid Level and Liver Fibrosis in Obese Patients
An observational study of Hyperuricemia and NAFLD (Nonalcoholic Fatty Liver Disease), run by Assiut University.
Trial summary
1. Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients. 2. Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, NAFLD (Nonalcoholic Fatty Liver Disease), Liver Fibrosis
- What is being tested?
- *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level ., *Imaging Studies:* 1- Ultrasound 2 - FibroScan and Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult obese patients
Who may be able to join
- Age: Adults (typically 18-65 years old)
- 2 - Body Mass Index (BMI): Obese patients with a BMI ≥ 30 kg/m²
- 3- Hyperuricemia : Elevated serum uric acid levels (typically > 7 mg/dL for men and > 6 mg/dL for women)
Who cannot join
- excessive alcohol consumption ( > 20 gm /day in men and 10 in g /day in women )
- 2- use of steatogenic within the past 6 months
- 3- positive test for hepatitis B surface antigen and hepatitis B core antibody
- 4- Drug induced liver injury and autoimmune hepatitis
- 5 - cirrhosis and other causes of liver disease
About this study
Official title: Association of Hyperuricemia and Non Alcoholic Fatty Liver Disease and Liver Fibrosis Risk in Adult Obese Patients
- Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients.
- Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression.
3 - To examine the relationship between serum uric acid levels and liver fibrosis severity*: Assessing the correlation between serum uric acid levels and the severity of liver fibrosis in adult obese patients with NAFLD.
4- To identify potential mechanisms underlying the association*: Exploring the potential mechanisms by which hyperuricemia may contribute to the development and progression of NAFLD and liver fibrosis in adult obese patients.
Read the detailed description
Hyperuricemia is associated with nonalcoholic fatty liver disease (NAFLD), whereas whether the association differed by hyperuricemia onset age remained unclear. This study sought to investigate the associations of hyperuricemia onset age with the risk of incident NAFLD across adulthood.
Obesity has been demonstrated to show a consistent link with the increased possibility of nonalcoholic fatty liver disease (NAFLD). Since both serum uric acid (SUA) and obesity are essential components of metabolic syndrome (MetS), it is uncertain whether the incidence of NAFLD results from serum uric acid, obesity, or other potential factors based on previous studies.
- Being tested
- *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level ., *Imaging Studies:* 1- Ultrasound 2 - FibroScan, Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.
- Medical subject headings
- Hyperuricemia, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
*Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level .Diagnostic test
Lab methods
*Imaging Studies:* 1- Ultrasound 2 - FibroScanRadiation
Imaging
Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.Device
Instrument
| Study group | Role | What they receive |
|---|---|---|
| 1- obese +-nafld+- fibrosis | Obese patients with non alcoholic fatty liver disease with fibrosis Receives: Diagnostic Test: *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level .; Radiation: *Imaging Studies:* 1- Ultrasound 2 - FibroScan; Device: Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests. | |
| obese +- hyperuricemia +- nfld+- fibrosis | Obese patients with hyperuricemia and non alcoholic liver disease and fibrosis Receives: Diagnostic Test: *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level .; Radiation: *Imaging Studies:* 1- Ultrasound 2 - FibroScan; Device: Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests. | |
| Healthy controls | Healthy controls Receives: Diagnostic Test: *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level .; Radiation: *Imaging Studies:* 1- Ultrasound 2 - FibroScan; Device: Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD
The proportion of adult obese patients with NAFLD in the study population
Measured: 1 year
Secondary outcomes (1)
Serum uric acid level
The serum uric acid level in adult obese patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Adel Mahmoud Abu Shady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168551
- Sponsor's protocol ID
- UNLF
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Hyperuricemia and Non Alcoholic Fatty Liver Disease and Liver Fibrosis Risk in Adult Obese Patients
- ClinicalTrials.gov ID
- NCT07168551
- Acronym / sponsor ID
- UNLF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Sep 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.
- Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients.
- Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression.
3 - To examine the relationship between serum uric acid levels and liver fibrosis severity*: Assessing the correlation between serum uric acid levels and the severity of liver fibrosis in adult obese patients with NAFLD.
4- To identify potential mechanisms underlying the association*: Exploring the potential mechanisms by which hyperuricemia may contribute to the development and progression of NAFLD and liver fibrosis in adult obese patients.
Detailed description
Hyperuricemia is associated with nonalcoholic fatty liver disease (NAFLD), whereas whether the association differed by hyperuricemia onset age remained unclear. This study sought to investigate the associations of hyperuricemia onset age with the risk of incident NAFLD across adulthood.
Obesity has been demonstrated to show a consistent link with the increased possibility of nonalcoholic fatty liver disease (NAFLD). Since both serum uric acid (SUA) and obesity are essential components of metabolic syndrome (MetS), it is uncertain whether the incidence of NAFLD results from serum uric acid, obesity, or other potential factors based on previous studies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- obese +-nafld+- fibrosis | – | Diagnostic Test: *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level ., Radiation: *Imaging Studies:* 1- Ultrasound 2 - FibroScan, Device: Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.Obese patients with non alcoholic fatty liver disease with fibrosis |
| obese +- hyperuricemia +- nfld+- fibrosis | – | Diagnostic Test: *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level ., Radiation: *Imaging Studies:* 1- Ultrasound 2 - FibroScan, Device: Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.Obese patients with hyperuricemia and non alcoholic liver disease and fibrosis |
| Healthy controls | – | Diagnostic Test: *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level ., Radiation: *Imaging Studies:* 1- Ultrasound 2 - FibroScan, Device: Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.Healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult obese patients
Key inclusion criteria (3 listed)
- Age: Adults (typically 18-65 years old)
- 2 - Body Mass Index (BMI): Obese patients with a BMI ≥ 30 kg/m²
- 3- Hyperuricemia : Elevated serum uric acid levels (typically > 7 mg/dL for men and > 6 mg/dL for women)
Key exclusion criteria (5 listed)
- excessive alcohol consumption ( > 20 gm /day in men and 10 in g /day in women )
- 2- use of steatogenic within the past 6 months
- 3- positive test for hepatitis B surface antigen and hepatitis B core antibody
- 4- Drug induced liver injury and autoimmune hepatitis
- 5 - cirrhosis and other causes of liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| *Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level .Lab methods | Diagnostic test | 1- obese +-nafld+- fibrosis, Healthy controls, obese +- hyperuricemia +- nfld+- fibrosis |
| *Imaging Studies:* 1- Ultrasound 2 - FibroScanImaging | Radiation | 1- obese +-nafld+- fibrosis, Healthy controls, obese +- hyperuricemia +- nfld+- fibrosis |
| Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.Instrument | Device | 1- obese +-nafld+- fibrosis, Healthy controls, obese +- hyperuricemia +- nfld+- fibrosis |
Primary outcome
Prevalence of NAFLD
Time frame: 1 year
The proportion of adult obese patients with NAFLD in the study population
1 secondary outcome
Serum uric acid level
Time frame: 1 year
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 15 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia and NAFLD (Nonalcoholic Fatty Liver Disease), run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence of NAFLD (time frame: 1 year). 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 15 Sep 2025.