| 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
|
|
|
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
|
|
|
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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