Clinical trial NCT05974904: Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Controlled attenuation parameter
timeFrame: at baseline
Secondary outcomes:
measure: Liver stiffness measurement
timeFrame: at baseline
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Tingqiu Wang, Bachelor
role: STUDY_DIRECTOR
References:
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.
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.
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.