Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-30 @ 9:36 PM
Study NCT ID:
NCT05974904
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2023-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Medical history electronic data'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Controlled attenuation parameter', 'timeFrame': 'at baseline', 'description': 'Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis'}], 'secondaryOutcomes': [{'measure': 'Liver stiffness measurement', 'timeFrame': 'at baseline', 'description': 'Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-sensitivity C-reactive protein to albumin ratio', 'metabolic dysfunction-associated fatty liver disease', 'National Health and Nutrition Examination Survey', 'control attenuation parameter', 'liver stiffness measurement', 'inflammation'], 'conditions': ['Metabolic Dysfunction-associated Fatty Liver Disease', 'Hepatic Steatosis', 'Liver Fibrosis']}, 'referencesModule': {'references': [{'pmid': '32278004', 'type': 'BACKGROUND', 'citation': 'Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.'}, {'pmid': '30689971', 'type': 'BACKGROUND', 'citation': 'Eddowes PJ, Sasso M, Allison M, Tsochatzis E, Anstee QM, Sheridan D, Guha IN, Cobbold JF, Deeks JJ, Paradis V, Bedossa P, Newsome PN. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 May;156(6):1717-1730. doi: 10.1053/j.gastro.2019.01.042. Epub 2019 Jan 25.'}, {'pmid': '34745112', 'type': 'BACKGROUND', 'citation': 'Karimi A, Shobeiri P, Kulasinghe A, Rezaei N. Novel Systemic Inflammation Markers to Predict COVID-19 Prognosis. Front Immunol. 2021 Oct 22;12:741061. doi: 10.3389/fimmu.2021.741061. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD).\n\nThe main question\\[s\\] it aims to answer are:\n\n\\[question 1\\] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? \\[question 2\\] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?', 'detailedDescription': 'Background Inflammation is related to the occurrence and development of fatty liver. Our research aimed to investigate the link between an inflammatory indicator, high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD).\n\nMethods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the NHANES database, respectively. The relationship between hsCAR and MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same methodology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'They all come from the National Health and Nutrition Examination Survey, which is a database that contains information about demographics, dietary, examination, laboratory and questionnaire of the American population obtained through sophisticated sampling strategies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total participants from NHANES 2017-2020\n* Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver disease (MAFLD) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.\n\n 1. Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥ 6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); (4) 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L (200 mg/dL).\n 2. Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians\n 3. If presence of at least two metabolic risk abnormalities:\n\n * Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in Asian men and women)\n * Blood pressure≥130/85 mmHg or specific drug treatment\n * Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment\n * Plasma HDL-cholesterol \\<40 mg/dl (\\<1.0 mmol/L) for men and \\<50 mg/dl (\\<1.3 mmol/L) for women or specific drug treatment\n * Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl \\[5.6 to 6.9 mmol/L\\], or 2-hour post-load glucose levels 140 to 199 mg/dl \\[7.8 to 11.0 mmol\\] or HbA1c 5.7% to 6.4% \\[39 to 47 mmol/mol\\])\n * Homeostasis model assessment of insulin resistance score≥2.5\n * Plasma high-sensitivity C-reactive protein level \\>2 mg/L\n\nExclusion Criteria:\n\n* Liver ultrasound data not available\n* participants without complete clinical data\n* participants under 18 years old\n* participants with cancer.'}, 'identificationModule': {'nctId': 'NCT05974904', 'briefTitle': 'Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study', 'orgStudyIdInfo': {'id': 'ChongqingMUU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-MAFLD group', 'description': 'controlled attenuation parameter\\<274 dB/m'}, {'label': 'MAFLD group', 'description': 'controlled attenuation parameter ≥ 274 dB/m', 'interventionNames': ['Other: high-sensitivity C-reactive protein to albumin ratio']}, {'label': 'Non-fibrosis group', 'description': 'liver stiffness measurement \\< 8.2 kPa'}, {'label': 'Fibrosis group', 'description': 'liver stiffness measurement ≥ 8.2 kPa', 'interventionNames': ['Other: high-sensitivity C-reactive protein to albumin ratio']}], 'interventions': [{'name': 'high-sensitivity C-reactive protein to albumin ratio', 'type': 'OTHER', 'description': 'High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.', 'armGroupLabels': ['Fibrosis group', 'MAFLD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingqiu Wang, Bachelor', 'role': 'CONTACT', 'email': 'w857683014@163.com', 'phone': '17815370539'}], 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Tingqiu Wang, Bachelor', 'role': 'CONTACT', 'email': 'w857683014@163.com', 'phone': '+8617815370539'}, {'name': 'Zhigang Luo, Master', 'role': 'CONTACT', 'email': '306395@hospital.cqmu.edu.cn', 'phone': '+8618989126596'}], 'overallOfficials': [{'name': 'Tingqiu Wang, Bachelor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tingqiu Wang', 'investigatorAffiliation': 'Chongqing Medical University'}}}}