Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study

Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study

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).

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?

Study Overview

• Status: Recruiting
• Conditions: Hepatic Steatosis; Liver Fibrosis; Metabolic Dysfunction-associated Fatty Liver Disease
• Intervention / Treatment: Other: high-sensitivity C-reactive protein to albumin ratio

Detailed Description

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).

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.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Tingqiu Wang, Bachelor; Phone Number: +8617815370539; Email: w857683014@163.com
• Study Contact Backup: Name: Zhigang Luo, Master; Phone Number: +8618989126596; Email: 306395@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Tingqiu Wang, Bachelor; Phone Number: 17815370539; Email: w857683014@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Total participants from NHANES 2017-2020

• 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:

• Liver ultrasound data not available
• participants without complete clinical data
• participants under 18 years old
• participants with cancer.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-MAFLD group; controlled attenuation parameter<274 dB/m
MAFLD group; controlled attenuation parameter ≥ 274 dB/m	Other: 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
Fibrosis group; liver stiffness measurement ≥ 8.2 kPa	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Controlled attenuation parameter	Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver stiffness measurement	Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness	at baseline

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Study Director: Tingqiu Wang, Bachelor, The Second Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: inflammation; liver stiffness measurement; high-sensitivity C-reactive protein to albumin ratio; metabolic dysfunction-associated fatty liver disease; National Health and Nutrition Examination Survey; control attenuation parameter
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Fibrosis; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
• Other Study ID Numbers: ChongqingMUU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No