Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study
NCT ID: NCT05974904
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7000 participants
OBSERVATIONAL
2023-07-18
2026-12-28
Brief Summary
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The main question\[s\] it aims to answer are:
\[question 1\] 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?
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Detailed Description
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Methods 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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Non-MAFLD group
controlled attenuation parameter\<274 dB/m
No interventions assigned to this group
MAFLD group
controlled attenuation parameter ≥ 274 dB/m
high-sensitivity C-reactive protein to albumin ratio
High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.
Non-fibrosis group
liver stiffness measurement \< 8.2 kPa
No interventions assigned to this group
Fibrosis group
liver stiffness measurement ≥ 8.2 kPa
high-sensitivity C-reactive protein to albumin ratio
High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.
Interventions
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high-sensitivity C-reactive protein to albumin ratio
High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.
Eligibility Criteria
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Inclusion Criteria
* 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.
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).
2. Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
3. If presence of at least two metabolic risk abnormalities:
* Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in Asian men and women)
* Blood pressure≥130/85 mmHg or specific drug treatment
* Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment
* 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
* 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% \[39 to 47 mmol/mol\])
* Homeostasis model assessment of insulin resistance score≥2.5
* Plasma high-sensitivity C-reactive protein level \>2 mg/L
Exclusion Criteria
* participants without complete clinical data
* participants under 18 years old
* participants with cancer.
18 Years
90 Years
ALL
No
Sponsors
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Chongqing Medical University
OTHER
Responsible Party
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Tingqiu Wang
Principal Investigator
Principal Investigators
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Tingqiu Wang, Bachelor
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Chongqing Medical University
Locations
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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ChongqingMUU
Identifier Type: -
Identifier Source: org_study_id
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