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NCT Number: NCT05974904

Association of HsCAR with MAFLD 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?

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location status: Recruiting

Location contact

Tingqiu Wang, Bachelor

CONTACT

[email protected]

17815370539

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Controlled attenuation parameter

    Time frame: at baseline

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

Secondary outcomes

  1. Liver stiffness measurement

    Time frame: at baseline

    Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness

Study contacts

Contact information is provided by the study sponsor or research team.

Tingqiu Wang, Bachelor

CONTACT

[email protected]

+8617815370539

Zhigang Luo, Master

CONTACT

[email protected]

+8618989126596

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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