Association of hsCAR With MAFLD and Liver Fibrosis: A Cross-sectional Study

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974904
• Other study ID #: ChongqingMUU
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: December 28, 2024

Study information

• Verified date: February 2024
• Source: Chongqing Medical University
• Contact: Tingqiu Wang, Bachelor
• Phone: +8617815370539
• Email: w857683014[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Hepatic Steatosis
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Non-alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Controlled attenuation parameter	Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis	at baseline
Secondary	Liver stiffness measurement	Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness	at baseline