| CTRI Number |
CTRI/2021/11/038242 [Registered on: 24/11/2021] Trial Registered Prospectively |
| Last Modified On: |
23/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on prevalence of Metabolic syndrome and risk factors among adolescents in Delhi |
|
Scientific Title of Study
|
A community based study on the prevalence of Metabolic syndrome and associated risk factors among adolescents in a resettlement colony of Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urwashi |
| Designation |
Postgraduate student |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadurshah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
commedicine.urwashi.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Sharma |
| Designation |
Director Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadurshah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drnandini1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urwashi |
| Designation |
Postgraduate student |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadurshah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
7678425781 |
| Fax |
|
| Email |
commedicine.urwashi.2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college, Bhadurshah zafar marg, New delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Dr Urwashi |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadurshah zafar marg, New Delhi |
| 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 Urwashi |
MAMC and associated hospital |
Room no 325, Department of Community Medicine, Maulana azad medical college and associated hospital, New Delhi 110002
Central
DELHI |
7678425781
commedicine.urwashi.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
E88.81 |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Residing for more than 6 months in field practice area of Department of community medicine, Maulana azad medical college at UHTC Gokalpuri with abdominal obesity |
|
| ExclusionCriteria |
| Details |
Children who are hospitalised with any debilitating disease will be excluded. The cases with diagnosed endocrine or metabolic (except diagnosed cases of Diabetes and Metabolic syndrome) or kidney disease or on any glucose altering drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Metabolic syndrome |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association of metabolic syndrome with demographic, socio-economic, biological, behavioral and metabolic factors. |
5 months |
|
|
Target Sample Size
|
Total Sample Size="2450"
Sample Size from India="2450"
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)
|
01/12/2021 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a community based cross sectional study to find out prevalence of Metabolic syndrome and its associated risk factors among adolescents residing at UHC Gokalpuri, the field practice area of Department of Community Medicine, Maulana Azad Medical College , Delhi. |