| 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
|
|
|
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
|
|
|
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. |