| 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
|
|
|
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
|
|
|
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. |