FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065281 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of correlation between anthropometric parameters and visceral fat in overweight and obese children in age group of 5-18 years. 
Scientific Title of Study   Study of dyslipidemia in overweight and obese children in age group of 5-18 years and it’s correlation with anthropometric parameters and visceral fat. 
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 Riddhi Jadhav 
Designation  Pediatric resident 
Affiliation  Bhaktivedanta Hospital And Research Institute 
Address  OPD No 1, Ground floor, Sector 1 Srishti Complex Bhaktivedanta Swami Marg, Mira road (east) Thane 401107

Thane
MAHARASHTRA
401107
India 
Phone  09920906765  
Fax    
Email  jadhavriddhi2203@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samrat Mehta 
Designation  Head of Department. 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD no 1, Ground floor, Sector 1 Srishti Complex, Bhaktivedanta Swami Marg, Mira road (east) Thane 401107

Thane
MAHARASHTRA
401107
India 
Phone  9869407734  
Fax    
Email  samratbvh@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Riddhi Jadhav 
Designation  Pediatric Resident 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No 1, Ground Floor Sector 1 Srishti Complex Bhaktivedanta Swami Marg, Mira Road (east) Thane 401107

Thane
MAHARASHTRA
401107
India 
Phone  09920906765  
Fax    
Email  jadhavriddhi2203@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta HospitaL and Research Institute. Srishti Complex, Sector-3 Bhaktivedanta Swami Marg Mira Road East Thane-401107,Maharashtra,India. 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute  
Address  Sector 1 Shristi Complex, Bhaktivedanta Swami Marg, Mira Road East. Thane-401107 
Type of Sponsor  Research institution and hospital 
 
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 Riddhi Jadhav  Bhaktivedanta Hospital and Research Institute  OPD No 1 Ground Floor Sector 1 Srishti Complex Bhaktivedanta Swami Marg, Mira Road East. Thane-401107,India.
Thane
MAHARASHTRA 
9920906765

jadhavriddhi2203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committe for Biomedical and Health Research.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. All children of age group 5-18 years whose BMI falls in the range of 23-27 adult percentile of curve as overweight and above 27 percentile as obese as per the Revised IAP guidelines for height, weight, BMI for 5-18 years of age group.
2. Children of both gender will be included in the study.
 
 
ExclusionCriteria 
Details  1. Any child with a pre-existing Type 1 Diabetes, hypertension, Congenital heart disease, moderate-severe asthma, metabolic disorders, nephrotic syndrome.
2. Child on immunosuppressive drug therapy, steroids.
3. Children with history of recent surgery, fracture, or requiring hospitalization.
4. Children with obese dysmorphism and developmental delay.
5. Children who are known case of Cushing syndrome, and other endocrine abnormalities and familial dyslipidemia.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study correlation between lipid profile and visceral fat and to assess the correlation between lipid profile and anthropometric parameters
 
Outcome will be achieved after 3 years
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study dietary habits and physical activity correlation with obesity in children.  outcome will be achieved after 3 years 
 
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)   16/04/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Pediatric overweight is a major factor in the adulthood obesity epidemic, translating into an increased mortality and morbidity burden in adult life. Characterized by excessive fat accumulation, overweight is influenced by genetic and environmental factors, including diet and physical activity (PA) While the health consequences of pediatric overweight are still poorly studied compared to adults, pediatric overweight has been consistently reported as a key risk factor for future metabolic conditions, such as type 2 diabetes mellitus, metabolic syndrome, cardiovascular diseases, and certain types of cancer. Therefore, pediatric overweight and obesity can be deleterious to quality of life with associated emotional and behavioural problems due to children acquiring the cultural values of beauty and aesthetics considerably before puberty. (1) [1]. The development of overweight in children and adolescents is complex, with several risk factors and interrelated mechanisms. Among the environmental components of overweight and obesity, lifestyle habits, such as little or no PA, unbalanced eating habits, and sleeping disorders, seem to be decisive determinants Some socio-economic and cultural factors also impact children’s health. Screen time, inconsistent sports practice, and unhealthy food habits seem to be positively associated with lower socio-economic status, as assessed by parental education and wealth indicators Furthermore, ethnic disparities regarding overweight and the parental misperception of childhood excess weight may also play a role. Lately, the COVID-19 pandemic imposed worldwide measures, such as lockdowns, leading to even longer children’s sleep time, leisure-based screen activity, unhealthy food choices, and sedentarism.

This is something that should be monitored with attention, since overweight at this stage of life can trigger patterns of obesity in adulthood.(1)

Several different anthropometric indicators have been employed to identify overweight and obesity in children and adolescents. Body mass index (BMI), which is widely used in epidemiological studies, indicates fat in general, whereas waist circumference (WC) and the conicity index (C index) identify fat located in the central part of the body. The waist-height ratio (WHR) illustrates the proportion of centralized fat as a function of a person’s height. All of these indicators have been tested with success as predictors of the principal cardiovascular risk factors in paediatric   populations. (2)  Unhealthy changes to the lipid profile are important cardiovascular risk factors and can be represented, among other variables, by elevated total cholesterol (TC) and by a low proportion of high density lipoproteins (HDL-C). Lipid abnormalities have been detected in adolescents in India and in many other parts of the world but in this population there is no routine screening and control for these unhealthy changes using laboratory tests. (2) and by a low proportion of high density lipoproteins (HDL-C). Lipid abnormalities have been detected in adolescents in India and in many other parts of the world but in this population there is no routine screening and control for these unhealthy changes using laboratory tests. (2)

Lipid abnormalities, or lipid triad, are characterized by low levels of HDL-C, high triglycerides, and increased numbers of small dense LDL particles, which are more atherogenic. These abnormalities are also known as combined dyslipidemia . The triad is accompanied by a host of other associated lipid abnormalities, Pathophysiology of the obesity-related lipid triad is lack of sensitivity of the metabolically active adipocyte to the regulatory effects of insulin and acylation stimulating protein result in the increased release of circulating free fatty acids. These contribute excessive substrate for triglyceride production, stimulate production of apolipoprotein B in the liver, which are then incorporated into an increased production of triglyceride-enriched VLDL particles. Triglyceride from VLDL is exchanged with cholesterol esters from both LDL and HDL particles, a process mediated by cholesterol ester transfer protein. Hepatic lipase metabolizes the triglyceride content of both HDL and LDL, resulting in smaller, denser particles. For LDL, this results in a more atherogenic particle, and for HDL, this results in increased catabolism and clearance. (5)

Developing countries like India have a unique problem of ‘double burden’ wherein at one end of the spectrum we have obesity in children and adolescents while at the other end we have malnutrition and underweight. 70% of obese or overweight children have at least one clinical cardiovascular risk factor; dyslipidemia, high blood pressure, or insulin resistance. With the increasing prevalence of obesity, various forms of comorbidities are seen in children including dyslipidemia and nonalcoholic fatty liver disease (NAFLD). Liver disease and dyslipidemia are major comorbidities for obesity at a young age(3)

Many of the complications of obesity seen in adults appear to be related to increased accumulation of visceral fat. It has been proposed that subcutaneous fat may be protective against the adverse effects of visceral fat. Males typically accumulate fat in the upper segment of the body, both subcutaneously and intraabdominally. In females, adiposity is usually subcutaneous and is found particularly over the thighs, although visceral fat deposition also occurs. Gender-related patterns of fat deposition become established during puberty and show significant familial associations. There are no reliable means for assessing childhood and adolescent visceral fat other than radiologically. Noninsulin-dependent diabetes is being seen more commonly in the pediatric population. Diabetes and impaired glucose tolerance are noted particularly in obese children with a family history of diabetes. In this situation, a glucose tolerance test may be indicated, even in the presence of fasting normoglycemia. Hypertriglyceridemia and low high-density lipoprotein–cholesterol levels are the primary lipid abnormalities of obesity and are related primarily to the amount of visceral fat. Low-density lipoprotein–cholesterol levels are not typically elevated in simple obesity. (4)

The objective of this study is to find correlation of anthropometric indicators of overweight and obesity with lipid abnormalities and insulin resistance in children and visceral fat.

 
Close