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Association Between Fatty Liver and Inflammatory Biomarkers

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07636915
Acronym
MASLD
Enrollment
100
Registered
2026-06-09
Start date
2026-07-01
Completion date
2027-03-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

MASLD

Brief summary

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.

Interventions

None listed

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

1. Significant alcohol consumption (\>20 g/day for females, \>30 g/day for males). 2. Other causes of chronic liver disease: * Viral hepatitis (HBV, HCV) * Autoimmune hepatitis. * Wilson's disease. * Hemochromatosis. * Drug-induced liver injury. 3. Active infection or acute inflammatory conditions. 4. Malignancy. 5. Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between systemic inflammatory indexes and MASLDAt enrollmentTo evaluate the statistical correlation between different systemic inflammatory indexes (including NLR, PLR, NPAR, SII, and SIRI) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The correlation will be assessed using Pearson's or Spearman's correlation coefficients based on the normality of data distribution.

Countries

Egypt

Contacts

CONTACTAlaa N Mohamed, MBBCh
alaa_naser_post@med.sohag.edu.eg01140559397
PRINCIPAL_INVESTIGATORSafaa Kh Abdalla, MD

Sohag University, Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026