Association Between Fatty Liver and Inflammatory Biomarkers

NCT07636915 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-5-2MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Fatty Liver

Keywords

MASLD

Outcome Measures

Primary Outcomes (1)

• Correlation between systemic inflammatory indexes and MASLD

  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.

  At enrollment

Study Arms (1)

MASLD patients

Patients older than 18 years were diagnosed with MASLD according to Delphi consensus criteria , patients will undergo complete history , examination and the following investigations, including : CBC , lipid profile, serum creatinine , serology and abdominal ultrasound then inflammatory biomarkers will be calculated : * Neutrophil-to-Lymphocyte Ratio (NLR). * Platelet-to-Lymphocyte Ratio (PLR). * Neutrophil-to-Albumin Ratio (NPAR). * Systemic Immune-Inflammatory Index (SII)= (Platelet count × Neutrophil count) / Lymphocyte count. * Systemic Inflammatory Response Index (SIRI) = (Neutrophil count × Monocyte count) / Lymphocyte count. to evaluate inflammatory biomarkers in MASLD patients .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Suhag university , faculty of medicine

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC , liver function test , lipid profile , serology

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Safaa Kh Abdalla, MD

  Sohag University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa N Mohamed, MBBCh

CONTACT

01140559397; alaa_naser_post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at tropical medicine and gastroenterology department

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

EG (1)