| CTRI Number |
CTRI/2026/01/100128 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study in adults to find out how common fatty liver not due to alcohol is on ultrasound and whether it is linked to insulin resistance |
|
Scientific Title of Study
|
Prevalence of non alcoholic Fatty Liver Disease (NAFLD)
Diagnosed by Ultrasound Abdomen and its Association with
Insulin Resistance Measured by HOMA-IR. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupam Aji |
| Designation |
General Medicine Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8848084858 |
| Fax |
|
| Email |
anupam.aji99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Arulmurugan |
| Designation |
Professor,Head of the Department, Department of General Medicine |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College And Hospitals,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8248646877 |
| Fax |
|
| Email |
dr.arulc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupam Aji |
| Designation |
General Medicine Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College And Hospitals,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8848084858 |
| Fax |
|
| Email |
anupam.aji99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem ,Tamil Nadu ,India,pin code 636308 |
|
|
Primary Sponsor
|
| Name |
Dr Anupam Aji |
| Address |
Department of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem ,Tamil nadu,India,pin code 636308 |
| 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 Anupam Aji |
Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem |
OPD Number 16, Department Of General Medicine, Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Salem
Salem
TAMIL NADU |
8848084858
anupam.aji99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Kirupananda Variyar Medical College And Hospitals, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E788||Other disorders of lipoprotein metabolism, |
|
|
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 |
Patients diagnosed with fatty liver on ultrasound ,Grades I to III
Patients who have undergone fasting blood glucose and fasting insulin testing for HOMA IR calculation.
Patients who consent to participate in the study.
5. Patients with Type 2 Diabetes Mellitus
|
|
| ExclusionCriteria |
| Details |
1 Known cases of Type 1 Diabetes Mellitus.
2 Patients on medications affecting insulin sensitivity (example glucocorticoids, metformin).
3 Significant alcohol intake (more than 20 g per day in females, more than 30 g perday in males).
4 Patients with chronic liver diseases other than fatty liver (e.g., viral hepatitis, autoimmune hepatitis, Wilsons disease).
5 Pregnant or lactating women.
6 Critically ill or hospitalised patients with acute systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between HOMA IR values and ultrasound graded severity of non alcoholic fatty liver disease. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Non-alcoholic fatty liver disease (NAFLD) is emerging as a major public health problem, closely linked with obesity, insulin resistance, and type 2 diabetes. Early identification of patients at risk is essential to prevent progression to steatohepatitis, fibrosis, and cirrhosis. This cross-sectional study evaluates the prevalence of NAFLD diagnosed by abdominal ultrasonography and examines its association with insulin resistance measured using the HOMA IR index. Adults aged 18 to 65 years with ultrasound-confirmed fatty liver (Grades I to III) and available fasting glucose and insulin values are enrolled. Anthropometry and relevant clinical data are recorded. Correlation between HOMA IR and ultrasound grading is analyzed using Spearmans correlation, with additional comparisons across grades. Secondary analyses explore relationships with BMI and waist circumference. The study aims to determine whether higher HOMA IR values predict more severe fatty liver, thereby supporting HOMA IR as a simple, affordable surrogate marker to complement imaging and guide early intervention in resource limited settings. |