Association Between Fatty Liver and Inflammatory Biomarkers

Official title

Association Between Systemic Inflammatory Indexes and Metabolic Dysfunction Associated Steatotic Liver Disease

Overview

The newly adapted definition for MASLD includes evidence for hepatic steatosis by imaging or biopsy with at least one of the five cardiometabolic criteria; BMI ≥ 25 kg/m2 (≥23 kg/m2 in Asian) or waist circumference \>94 cm in men, \>80 cm in women, fasting serum glucose ≥ 126 mg/dL or 2 hour post load glucose level ≥ 140 mg/dL or HbA1c ≥ 5.7% or on treatment for type 2 diabetes mellitus ,blood pressure ≥130/85 mmHg or antihypertensive treatment, plasma triglycerides ≥ 150 mg/dL or on lipid lowering drug, and plasma HDL cholesterol \< 40 mg/dL for men and \< 50 mg/dL for women or on lipid lowering drug treatment (Rinella et al., 2024). These metabolic factors contribute to disease progression from simple steatosis to metabolic dysfunction-associated steatohepatitis (MASH), advanced fibrosis, cirrhosis, and hepatocellular carcinoma (Eid et al., 2024). While multiple biological pathways contribute to MASLD pathogenesis; systemic inflammation has emerged as a pivotal mechanism linking metabolic dysfunction to liver injury (Bessone et al., 2019)

Detailed description

These metabolic factors contribute to disease progression from simple steatosis to metabolic dysfunction-associated steatohepatitis (MASH), advanced fibrosis, cirrhosis, and hepatocellular carcinoma (Eid et al., 2024).

While multiple biological pathways contribute to MASLD pathogenesis; systemic inflammation has emerged as a pivotal mechanism linking metabolic dysfunction to liver injury (Bessone et al., 2019). Recently, inflammation indexes derived from blood cell counts have attracted considerable interest due to their cost effectiveness, simplicity, and ease of computation (Ma et al., 2024).

Neutrophil-to-Lymphocyte Ratio (NLR), an easily measurable parameter, serves as a comprehensive reflection of two distinct complementary immune pathways, encompassing innate (neutrophilic) and adaptive (lymphocyte) cellular unction as an inflammatory marker (Lobo et al., 2023). Platelet-to-Lymphocyte Ratio (PLR) is a novel hematologic inflammatory parameter that may provide insights into the development of inflammatory diseases to a certain extent. (Zhou et al ., 2021). The neutrophil-albumin ratio (NAR) combines data on chronic inflammation and metabolic conditions and demonstrates the best predictive performance for the risk of MASLD, with an AUC value of 0.813.(He et al., 2025) The systemic immune-inflammation index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) combine data from several immune pathways, offering a more comprehensive evaluation of inflammatory status (Wang et., al.2023). In this study we will assess the association between these inflammatory indexes and MASLD.

Primary outcome measures

• Correlation between systemic inflammatory indexes and MASLD [Time frame: At enrollment]

Eligibility criteria

Inclusion criteria

• Patient older than 18 years were diagnosed with MASLD according to Delphi consensus criteria (Rinella et al., 2024). Attend to outpatient clinic of Tropical Medicine Department, Sohag University

Exclusion criteria

• Significant alcohol consumption (>20 g/day for females, >30 g/day for males).
• Other causes of chronic liver disease:

• Viral hepatitis (HBV, HCV)
• Autoimmune hepatitis.
• Wilson's disease.
• Hemochromatosis.
• Drug-induced liver injury.
• Active infection or acute inflammatory conditions.
• Malignancy.
• Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Egypt · 1 center

• Suhag university , faculty of medicine — Sohag

Identifiers

NCT: NCT07636915 · Soh-Med-26-5-2MS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗