| CTRI Number |
CTRI/2025/12/099572 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Fatty liver index and Fibroscan parameters for detecting Metabolic dysfunction associated fatty liver disease in Indian adults |
|
Scientific Title of Study
|
Fatty liver index VS FIBROSCAN (Vibration controlled transient elastography ) in diagnosis of Metabolic dysfunction associated fatty liver disease -Balancing accuracy and accessibility in the Indian context |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praneetha Dandamudi |
| Designation |
Post Graduate |
| Affiliation |
Apollo Institute of Medical Sciences and Research |
| Address |
Department of General Medicine,
Apollo Institute of Medical Sciences and Research,Apollo health City Campus,Road No.92,Jubilee Hills ,Film Nagar,Hyderabad.
Hyderabad
TELANGANA
500096
India |
| Phone |
8897213196 |
| Fax |
|
| Email |
praneetha.d1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagender D |
| Designation |
Professor and HoD ,Department of General Medicine |
| Affiliation |
Apollo Institute of Medical Sciences and Research |
| Address |
Department of General Medicine,
Apollo Institute of Medical Sciences and Research,Apollo health City Campus,Road No.92,Jubilee Hills ,Film Nagar,Hyderabad.
Hyderabad
TELANGANA
500096
India |
| Phone |
9848036415 |
| Fax |
|
| Email |
ndevulapally1957@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagender D |
| Designation |
Professor and HoD ,Department of General Medicine |
| Affiliation |
Apollo Institute of Medical Sciences and Research |
| Address |
Department of General Medicine,
Apollo Institute of Medical Sciences and Research,Apollo health City Campus,Road No.92,Jubilee Hills ,Film Nagar,Hyderabad.
Hyderabad
TELANGANA
500096
India |
| Phone |
9848036415 |
| Fax |
|
| Email |
ndevulapally1957@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Institute of Medical Sciences and Research,Apollo Health City Campus, Film Nagar, Jubilee Hills, Hyderabad, Telangana
India ,500096 |
|
|
Primary Sponsor
|
| Name |
Praneetha Dandamudi |
| Address |
Department of General Medicine ,Apollo Institute of Medical Sciences and Research,Apollo Health City Campus, Film Nagar, Jubilee Hills, Hyderabad, Telangana ,India
500096 |
| Type of Sponsor |
Other [self] |
|
|
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 Praneetha Dandamudi |
Apollo Institute of Medical Sciences and Research |
Department of General Medicine,Apollo Institute of Medical Sciences and Research , Apollo Health City Campus ,Jubilee Hills,Hyderabad.
Hyderabad
TELANGANA |
8897213196
praneetha.d1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee ,Apollo Institute of Medical Sciences and Research ,Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Willing to give informed consent
2 Clinical suspicion of Metabolic dysfunction associated fatty liver diease based on metabolic risk factors like obesity T2Diabetes dyslipidemia
3 Able to undergo FibroScan and blood investigations
|
|
| ExclusionCriteria |
| Details |
1 Known history of significant alcohol consumption that is greater than 30g per day for men
greater than 20g per day for women to differentiate from alcoholic liver disease.
2 Presence of other known chronic liver diseases like viral hepatitis B or C
autoimmune hepatitis
primary biliary cholangitis
drug-induced liver injury
3 Presence of ascites or other conditions that may interfere with accurate FibroScan measurements.
4 Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the diagnostic accuracy of the Fatty Liver Index in detecting metabolic dysfunctionnassociated fatty liver disease (MAFLD), using FibroScan as the reference standard, as measured by sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic (ROC) curve. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the optimal cut-off value of the Fatty Liver Index for the diagnosis of MAFLD in the Indian population. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
31/12/2025 |
| 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="1"
Months="0"
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, formerly known as Non-Alcoholic Fatty Liver Disease NAFLD , is a significant global health challenge, affecting about a quarter of the worlds adult population. This high prevalence, fueled by sedentary lifestyles, low physical activity, and unhealthy diets, poses a major health and economic burden.MAFLD is defined by hepatic steatosis diagnosed via histology, imaging, or blood biomarkers alongside at least one of three criteria overweight/obesity, type 2 diabetes mellitus (T2DM), or evidence of metabolic dysregulation (defined by at least two specific metabolic risk abnormalities like elevated waist circumference, blood pressure, triglycerides, low HDL cholesterol, prediabetes, high HOMA IR, or elevated C reactive protein). For diagnosis of hepatic steatosis while ultrasonography is a first-line tool, it is subjective and operator-dependent. Liver biopsy, though a gold standard, is invasive, costly, carries risks, and is unsuitable for screening .These limitations highlight the critical need for simple, non-invasive diagnostic tools.Among serum based non-invasive tests , the Fatty Liver Index is considered appropriate due to its diagnostic and prognostic performance. FLI is a simple algorithm derived from readily available parameters such as Body Mass Index , waist circumference, serum triglycerides, and gamma-glutamyl transferase levels.HeFibroScan which assesses liver stiffness (fibrosis) and hepatic steatosis (via Controlled Attenuation Parameter, CAP), is another non-invasive option. While effective, FibroScan is relatively expensive, requires specialized equipment and trained operators, and can be influenced by factors like obesity.
Hence the present study aims to determine the prevalence of MAFLD and evaluate the diagnostic performance of FLI compared to FibroScan for detecting fatty liver in adults attending a tertiary care hospital in Telangana, India. |