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CTRI Number  CTRI/2025/09/094979 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to find the link between body measurements, blood tests, and liver health in overweight and obese adolescents 
Scientific Title of Study   Correlation of Anthropometric indices and Metabolic profile with Hepatic Transient Elastography in Overweight and Obese adolescents -A Cross Sectional 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  VAISHNAVI NAGIREDDY 
Designation  PG RESIDENT MD PAEDIATRICS 
Affiliation  Jawaharlal Nehru Medical College 
Address  PG RESIDENT OF PAEDIATRICS , Jawaharlal Nehru Medical College,KLE academy of higher education and research centre,Nehru Nagar Belagavi,Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8790872337  
Fax    
Email  vaishnavireddy2397@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MEENAKSHI BR 
Designation  ASSISTANT PROFESSOR DEPARTMENT OF PAEDIATRICS 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics,Jawaharlal Nehru Medical College,KLE academy of higher education and research centre,Nehru Nagar,Belagavi,Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  9900184188  
Fax    
Email  meenakshi.br@gmail.com  
 
Details of Contact Person
Public Query
 
Name  VAISHNAVI NAGIREDDY 
Designation  PG RESIDENT MD PAEDIATRICS 
Affiliation  Jawaharlal Nehru Medical College 
Address  PG RESIDENT OF PAEDIATRICS , Jawaharlal Nehru Medical College,KLE academy of higher education and research centre,Nehru Nagar Belagavi,Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8790872337  
Fax    
Email  vaishnavireddy2397@gmail.com  
 
Source of Monetary or Material Support  
Dr KLEs Prabhakar Kore Hospital and medical research centre Jawaharlal Nehru Medical College Nehru Nagar Belagavi 
 
Primary Sponsor  
Name  VAISHNAVI NAGIREDDY 
Address  Jawaharlal Nehru Medical College KLE academy of higher education and research centre Nehru Nagar Belagavi Karnataka 590010 
Type of Sponsor  Other [Self] 
 
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 VAISHNAVI NAGIREDDY  KLEs Dr Prabhakar Kore hospital and medical research centre  DEPARTMENT OF PAEDIATRICS JAWAHARLAL NEHRU MEDICAL COLLEGE NEHRU NAGAR
Belgaum
KARNATAKA 
8790872337

vaishnavireddy2397@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Ethical Institutional Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Overweight and Obese children who are more than and equal to 10 years and less than and equal to 18 years.
Overweight and Obesity defined by Body Mass Index Cut-off for Indian children gender and
age specific IAP 5 to 18years BMI chart.
International Obesity Task Force and who suggested lower cut off to defined
overweight and obesity in Asian children.
1.Overweight BMI greater than or equal to 23kg per metre square (Adult Equivalent)
2.Obesity BMI greater than or equal to 27kg per metre square (Adult Equivalent) 
 
ExclusionCriteria 
Details  1. Acute Hepatitis and Chronic Liver Disease
2. Inborn Error of Metabolism - Storage Disorders
3. Congenital Disorders of Liver and Biliary tract
3. Familial or genetic lipid disorders
4. Use of hepatotoxic medications
5. Type 1 diabetes mellitus
6. Endocrine, syndromic and monogenic obesity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the anthropometric indices and metabolic profile with
Transient hepatic elastography in overweight and obese
Adolescents aged 10 to 18 years
 
One year hospital based study 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the diagnostic utility of anthropometric indices as predictors of MAFLD  One year hospital based study 
To estimate the prevalence of MAFLD in overweight & obese
Adolescents
 
One year hospital based study 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   01/10/2025 
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 previously known as nonalcoholic fatty liver disease NAFLD represents a spectrum of progressive liver disorders ranging from simple steatosis to nonalcoholic steatohepatitis NASH fibrosis and cirrhosis. Recognized as the hepatic manifestation of metabolic syndrome MAFLD has demonstrated an increasing global prevalence including low and middle income countries traditionally considered at lower risk.


In the paediatric population MAFLD has emerged as one of the most prevalent causes of chronic liver disease. Its spectrum starts with isolated hepatic steatosis and may progress to NASH which involves hepatocellular inflammation and damage. This progression is particularly concerning in the context of the global surge in childhood obesity a principal risk factor for MAFLD across diverse socioeconomic and geographic settings.


Anthropometric indices including waist circumference WC waist to hip ratio WHR waist to height ratio WHtR and wrist circumference are practical and noninvasive tools to assess body fat composition and central adiposity in children. These indices have shown significant associations with liver fat accumulation and broader metabolic abnormalities.


Metabolic profiling typically comprising fasting blood glucose serum insulin lipid profile including total cholesterol HDL LDL and triglycerides and liver enzymes such as alanine aminotransferase ALT and aspartate aminotransferase AST offers critical insights into the metabolic health of obese children. These parameters often show derangements in the presence of MAFLD.


An international consensus in 2020 has proposed Metabolic dysfunction associated fatty liver disease MAFLD as a new name for NAFLD. Diagnosis of MAFLD is based on the radiological evidence of hepatic steatosis and the presence of at least one of the following criteria namely overweight obesity type 2 diabetes T2D or evidence of metabolic dysregulation defined as the presence of two or more of these conditions.

1 Waist circumference greater than 95th percentile for age and sex

2 Blood pressure greater than 95th for age sex and height

3 Triglycerides greater than 150 mg per dL

4 HDL less than 40 mg per dL

5 Prediabetes

6 Homeostasis model assessment insulin resistance HOMA IR score greater than 2.5


Given the invasiveness and risks associated with liver biopsy especially in paediatric populations noninvasive diagnostic modalities have become crucial for the early detection and staging of MAFLD.


Transient elastography FibroScan is a validated noninvasive imaging tool that measures liver stiffness LSM and the controlled attenuation parameter CAP allowing for the assessment of fibrosis and steatosis respectively. Although well established in adults its application in children remains underexplored despite promising early evidence.


FibroScan is used to measure stiffness in the right lobe of the liver. Speed of propagation of the wave in liver depends on its stiffness. The velocity of shear wave increases in proportion to the stiffness of the liver. The stiffness derived is in kilopascal KPa unit at a shear wave frequency of 50 Hz.


In India data on the prevalence and noninvasive assessment of MAFLD in overweight and obese children are scarce. This study aims to investigate the correlation between anthropometric indices and metabolic profiles with liver elastography FibroScan findings in overweight and obese children through which the research intends to study the associations between body fat composition metabolic status and liver health potentially guiding early screening and aiding intervention strategies in paediatric MAFLD.


 
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