FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068925 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Analytical 
Study Design  Other 
Public Title of Study   Detection of liver fat in Indian teenagers by ultrasound and MRI 
Scientific Title of Study   Comparison of Ultrasound Guided Attenuation Parameter and MRI Proton Density Fat Fraction in the assessment of hepatic steatosis in Indian adolescents: A pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Gajanan Hegde 
Designation  Associate Professor 
Affiliation  St. John’s Medical College 
Address  Department of Pediatric Surgery, 2nd floor, Extension block, St. John’s Medical College Hospital, Bangalore; 560034, Karnataka, India

Bangalore
KARNATAKA
560034
India 
Phone  9914208942  
Fax    
Email  shal.hegde@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pratibha Dwarkanath 
Designation  Associate Professor 
Affiliation  St. John’s Research Institute 
Address  Division of Nutrition, 3rd Floor, Department of Physiology, St. John’s Medical College, Bangalore; 560034, Karnataka, India

Bangalore
KARNATAKA
560034
India 
Phone  9880714118  
Fax    
Email  pratibha@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Shalini Gajanan Hegde 
Designation  Associate Professor 
Affiliation  St. John’s Medical College 
Address  Department of Pediatric Surgery, 2nd floor, Extension block, St. John’s Medical College Hospital, Bangalore; 560034, Karnataka, India

Bangalore
KARNATAKA
560034
India 
Phone  9914208942  
Fax    
Email  shal.hegde@gmail.com  
 
Source of Monetary or Material Support  
St. Johns Medical College Research Society Ground floor, St John’s Medical College, Sarjapur Road, Bengaluru - 560034 
 
Primary Sponsor  
Name  St. Johns Medical College Research Society 
Address  Ground floor, St John’s Medical College, Sarjapur Road, Bengaluru - 560034 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalini Gajanan Hegde  St. John’s Medical College Hospital  Room no 55 and 68, Department of Radiology, Ground floor,Sarjapur Road, Kormangala Bangalore 560034 Bangalore KARNATAKA
Bangalore
KARNATAKA 
9914208942

shal.hegde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St John’s Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z001||Encounter for newborn, infant andchild health examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  No history of liver disease (Hepatitis, tumours, surgery, or recent use of hepatotoxic drugs)
Parents and children (wherever applicable) willing to provide written consent for the study.
 
 
ExclusionCriteria 
Details  1.Motion artefacts that degrade MRI image quality.
2.General contraindications for MRI (Cardiac pacemakers, Cochlear and metallic implants, metallic foreign bodies)
3.Claustrophobia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare hepatic fat in Indian adolescents as assessed using UGAP with MRI PDFF methods   Single study day. (One point assessment at baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
To characterise the risk factors for the development of hepatic fat in Indian adolescents based on history, nutritional assessment & biochemical investigations
To correlate the percentage of hepatic fat / grades of steatosis as assessed through UGAP with MRI PDFF measurements with biochemical parameters
 
Single study day. (One point assessment at baseline) 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   25/06/2024 
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="2"
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  

Objectives : To compare hepatic fat in Indian adolescents as assessed using UGAP with MRI PDFF methods

Methodology: Details on SES, habitual dietary assessment, physical activity questionnaire, anthropometric measurements and a detailed clinical examination will be conducted for every subject. Biochemical analysis will be carried out in 4 ml of fasting venous blood samples collected at recruitment. Hemoglobin estimation, fasting blood sugar, serum HDL-cholesterol, serum triglycerides, serum aspartate aminotransferase and serum alanine aminotransferase will be estimated. All subjects will undergo total body composition measurement by the Dual energy X Ray absorptiometry DEXA machine. Hepatic fat quantification will be done in each subject using MRI PDFF and UGAP methods one after another. For MRI PDFF, a 3.0 T system GE Signa Architect will be used and a 3D volumetric, greater than 16sec breath hold sequence for fat quantification will be performed. UGAP will be performed for each subject by a single radiologist in the radiology suite using LOGIQ E10 ultrasound system GE Healthcare

Need of the study: Of concern in India, is that in national child surveys, an increase in biomarkers of metabolic obesity is occurring even in those children who apparently appear anthropometrically undernourished. On-invasive screening modality which can pick up early signs of ill-health or metabolic dysregulation in children is the need of the hour. This will help in instituting lifestyle changes, prevent tracking of disease into adulthood and reduce the burden of chronic disease. Though, MRI PDFF is accurate in detecting and quantifying hepatic fat, it is limited by accessibility and is inapplicable as a screening technique. UGAP can be performed in all ages, is portable and cost effective, but requires validation in Indian children for diagnostic accuracy with MRI PDFF.

 
Close