Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT07168551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is There a Relationship Between Uric Acid Level and Liver Fibrosis in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008111', 'term': 'Liver Function Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of NAFLD', 'timeFrame': '1 year', 'description': 'The proportion of adult obese patients with NAFLD in the study population'}], 'secondaryOutcomes': [{'measure': 'Serum uric acid level', 'timeFrame': '1 year', 'description': 'The serum uric acid level in adult obese patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia', 'NAFLD (Nonalcoholic Fatty Liver Disease)', 'Liver Fibrosis']}, 'descriptionModule': {'briefSummary': '1. Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients.\n2. Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression.\n\n3 - 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.\n\n4- 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.', 'detailedDescription': '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.\n\nObesity 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult obese patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: Adults (typically 18-65 years old)\n\n2 - Body Mass Index (BMI): Obese patients with a BMI ≥ 30 kg/m²\n\n3- Hyperuricemia : Elevated serum uric acid levels (typically \\> 7 mg/dL for men and \\> 6 mg/dL for women)\n\nExclusion Criteria:\n\n* excessive alcohol consumption ( \\> 20 gm /day in men and 10 in g /day in women )\n\n 2- use of steatogenic within the past 6 months\n\n 3- positive test for hepatitis B surface antigen and hepatitis B core antibody\n\n 4- Drug induced liver injury and autoimmune hepatitis\n\n 5 - cirrhosis and other causes of liver disease'}, 'identificationModule': {'nctId': 'NCT07168551', 'briefTitle': 'Is There a Relationship Between Uric Acid Level and Liver Fibrosis in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Association of Hyperuricemia and Non Alcoholic Fatty Liver Disease and Liver Fibrosis Risk in Adult Obese Patients', 'orgStudyIdInfo': {'id': 'UNLF'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1- obese +-nafld+- fibrosis', 'description': 'Obese patients with non alcoholic fatty liver disease with fibrosis', 'interventionNames': ['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.']}, {'label': 'obese +- hyperuricemia +- nfld+- fibrosis', 'description': 'Obese patients with hyperuricemia and non alcoholic liver disease and fibrosis', 'interventionNames': ['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.']}, {'label': 'Healthy controls', 'description': 'Healthy controls', 'interventionNames': ['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.']}], 'interventions': [{'name': '*Lab Methods:* 1- Serum Uric Acid levels 2-Liver Function Tests 3- Lipid Profile . 4- Haemoglobin A1c level . 5- Serum glucose level .', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lab methods', 'armGroupLabels': ['1- obese +-nafld+- fibrosis', 'Healthy controls', 'obese +- hyperuricemia +- nfld+- fibrosis']}, {'name': '*Imaging Studies:* 1- Ultrasound 2 - FibroScan', 'type': 'RADIATION', 'description': 'Imaging', 'armGroupLabels': ['1- obese +-nafld+- fibrosis', 'Healthy controls', 'obese +- hyperuricemia +- nfld+- fibrosis']}, {'name': 'Instruments:* 1- *Automated Analyzers*: Used for blood tests, such as serum uric acid and liver function tests.', 'type': 'DEVICE', 'description': 'Instrument', 'armGroupLabels': ['1- obese +-nafld+- fibrosis', 'Healthy controls', 'obese +- hyperuricemia +- nfld+- fibrosis']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internal medicine Resident doctor', 'investigatorFullName': 'Aya Adel Mahmoud Abu Shady', 'investigatorAffiliation': 'Assiut University'}}}}