Investigating a new inflammatory marker's link to fatty liver disease and liver fibrosis

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

This study is trying to see if a new blood marker can help doctors diagnose fatty liver disease and liver scarring in people who have these conditions.

Quick facts

• Study type: Observational
• Enrollment: 7000 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05974904 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between a novel inflammatory marker, the high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD) and liver fibrosis. Utilizing data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2020, the study will assess liver steatosis and fibrosis severity through ultrasonic indices. The researchers will employ multivariate logistic regression analysis and subgroup analyses to determine if hsCAR can serve as a clinical indicator for diagnosing MAFLD and identifying liver fibrosis in affected patients.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with MAFLD who also exhibit metabolic dysfunction, such as obesity or type 2 diabetes.

Not a fit: Patients without metabolic dysfunction or those not diagnosed with MAFLD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new clinical tool for early diagnosis and management of MAFLD and liver fibrosis.

How similar studies have performed: While the approach of using hsCAR as a clinical indicator is novel, similar studies have shown promise in linking inflammatory markers to liver diseases.

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.

Where this trial is running

Chongqing, Chongqing Municipality

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Tingqiu Wang, Bachelor

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