Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07636915

Association Between Fatty Liver and Inflammatory Biomarkers

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)

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Suhag university , faculty of medicine

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Correlation between systemic inflammatory indexes and MASLD

    Time frame: At enrollment

    To 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.

Study contacts

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

Alaa N Mohamed, MBBCh

CONTACT

[email protected]

01140559397

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: MASLD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 10, 2026

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.

Published trials that share one or more normalized conditions with this study.