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

NCT05974904 | Recruiting

• 1 other identifier: ChongqingMUU
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease; Hepatic Steatosis; Liver Fibrosis

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

Outcome Measures

Primary Outcomes (1)

• Controlled attenuation parameter

  Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis

  at baseline

Secondary Outcomes (1)

• Liver stiffness measurement

  at baseline

Study Arms (4)

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

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

Interventions

high-sensitivity C-reactive protein to albumin ratio OTHER

High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.

Fibrosis group; MAFLD group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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).
• Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (3)

• 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: 32278004 BACKGROUND

• 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: 30689971 BACKGROUND

• 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.

  PMID: 34745112 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Medical history electronic data

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis; Inflammation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tingqiu Wang, Bachelor

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Tingqiu Wang, Bachelor

CONTACT

+8617815370539; w857683014@163.com

Zhigang Luo, Master

CONTACT

+8618989126596; 306395@hospital.cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 3, 2023
• Study Start: July 18, 2023
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)