| CTRI Number |
CTRI/2025/06/089591 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Blood Markers Linked to Liver Scarring in People with Fatty Liver Disease |
|
Scientific Title of Study
|
The Relationship Between YKL-40, IL-6, and NFI in MAFLD-Related Liver Fibrosis: A Clinical Perspective |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aleena subhani |
| Designation |
MSc student |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, Delhi 110062, India
South
DELHI
110062
India |
| Phone |
5057274356 |
| Fax |
|
| Email |
subhanialeena4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Ashif Khan |
| Designation |
Assistant professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, Delhi 110062, India
South
DELHI
110062
India |
| Phone |
9891026397 |
| Fax |
|
| Email |
makhan@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Ashif Khan |
| Designation |
Assistant professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, Delhi 110062, India
South
DELHI
110062
India |
| Phone |
9891026397 |
| Fax |
|
| Email |
makhan@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard - Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062, India |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Jain |
Hakeem Abdul Hameed Centenary Hospital |
Room No. 91, Department of Medicine, Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI |
999907405
dr.vineet83@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee HIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70-K77||Diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Single Time Point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 |
Single Time Point |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |