The Relationship Between YKL-40, IL-6, and NFI in MAFLD-Related Liver Fibrosis: A Clinical Perspective
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Jamia Hamdard
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- To assess the correlation between serum levels of YKL-40 and IL-6 with liver fibrosis stages using the Novel Fibrosis Index (NFI) in MAFLD patients.
Study Overview
Brief Summary
Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic liver condition globally, closely linked to type 2 diabetes mellitus (T2DM), obesity, and metabolic syndrome. Non-invasive tools are increasingly being used to evaluate liver fibrosis in MAFLD, as liver biopsy is invasive and not practical for routine diagnosis. The Novel Fibrosis Index (NFI) is an emerging non-invasive score that combines clinical and metabolic parameters to assess fibrosis stages. Additionally, serum biomarkers like YKL-40 and inflammatory cytokines like IL-6 are known to be elevated in liver inflammation and fibrosis. This single-center, cross-sectional, hospital-based study aims to evaluate the serum levels of YKL-40 and IL-6 in MAFLD patients and correlate them with the stages of liver fibrosis as determined by NFI. The study also includes a healthy control group for comparative biomarker analysis. Blood samples will be analyzed using ELISA kits, and fibrosis staging will be done using non-invasive methods like FibroScan and NFI calculation. The study is being conducted at HAHC Hospital, Jamia Hamdard, New Delhi, and aims to include 150 participants (75 MAFLD patients and 75 healthy controls) over a period of 6 months. The outcomes may help establish YKL-40 and IL-6 as potential non-invasive biomarkers for liver fibrosis assessment in MAFLD.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants aged 18 to 65 years old Participants with a diagnosis of Metabolic dysfunction-associated fatty liver disease (MAFLD) confirmed by ultrasound and Fibroscan.
- •Presence of at least one metabolic risk factor, such as type 2 diabetes mellitus (T2DM), obesity, or metabolic dysregulation.
- •Willingness and ability to provide written informed consent.
- •Healthy human volunteers for controls.
Exclusion Criteria
- •History of significant alcohol consumption exceeding established thresholds for men and women.
- •Presence of coexisting chronic liver diseases or history of hepatotoxic drug use.
- •Advanced systemic illnesses or malignancies.
- •Patients having any other inflammatory diseases like arthritis, IBS Patients undergone any liver surgery or transplantation.
- •Patients having history of head injury, neurocognitive disorder, or any other neuronal disease.
- •Individuals with TB , any form of malignancies present or history of HIV-AIDS or any disease that could impair the biomarkers levels.
- •Individuals currently taking medications that significantly impact glucose metabolism or biomarker levels (e.g.corticosteroids, certain antipsychotics).
- •Individual with acute infection or inflammatory conditions at the time of recruitment.
- •Pregnant individuals or those planning to become pregnant during study period will be excluded due to potential confounding effects on biomarkers.
Outcomes
Primary Outcomes
To assess the correlation between serum levels of YKL-40 and IL-6 with liver fibrosis stages using the Novel Fibrosis Index (NFI) in MAFLD patients.
Time Frame: Single Time Point
Secondary Outcomes
- To validate the Novel Fibrosis Index (NFI) against Fibroscan & APRI(To assess the relationship between IL-6 & YKL-40 levels in MAFLD patients To compare YKL-40 levels with age, gender, BMI, & diet in MAFLD patients)