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CTRI Number  CTRI/2023/01/049151 [Registered on: 23/01/2023] Trial Registered Prospectively
Last Modified On: 21/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To find out risk of metabolic syndrome in an urban resettlement colony of Delhi 
Scientific Title of Study   A community-based study on Metabolic Syndrome and associated risk factors among adults 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 Shivani Rao 
Designation  Associate Professor,Department of community medicine 
Affiliation  Maulana Azad Medical college 
Address  Room no 337 Department of community medicine 3rd floor, Pathology block, Maulana Azad Medical College, 2BSZ marg

New Delhi
DELHI
110002
India 
Phone  9650729724  
Fax    
Email  shivani.idsp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Heena Lalwani 
Designation  Senior Project Manager 
Affiliation  Maulana Azad Medical college 
Address  Room no 368 Department of community medicine 3rd floor, Pathology block, Maulana Azad Medical College, 2BSZ marg

New Delhi
DELHI
110002
India 
Phone  8383048432  
Fax    
Email  heena.lalwani91@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Heena Lalwani 
Designation  Senior Project Manager 
Affiliation  Maulana Azad Medical college 
Address  Room no 368 Department of community medicine 3rd floor, Pathology block, Maulana Azad Medical College, 2BSZ marg


DELHI
110002
India 
Phone  8383048432  
Fax    
Email  heena.lalwani91@gmail.com  
 
Source of Monetary or Material Support  
Dept Of Community Medicine Maulana Azad medical college 
 
Primary Sponsor  
Name  Dept Of Community Medicine Maulana Azad medical college 
Address  Dept Of Community Medicine 3rd floor, Pathology block, Maulana Azad medical college, 2BSZ Marg, New Delhi 
Type of Sponsor  Government medical college 
 
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 Heena Lalwani  Urban Health centre,Department of Community Medicine,Maulana Azad Medical college  Urban Health centre, Gokalpuri 1st floor, DGHS clinic, Near post office Gokalpuri 110094
North East
DELHI 
8383048432

heena.lalwani91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  apparently healthy individuals  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adults above 18 years of age residing for more than 6 months in the study area. 
 
ExclusionCriteria 
Details  1. Persons who are hospitalized with any debilitating disease will be excluded.
2. 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 
Outcomes
1. Prevalence of metabolic syndrome cases amongst Adults.
2. Association of metabolic syndrome with the demographic (age, gender, etc.), socio-economic, biological, behavioral factors.
3. Level of medication adherence pattern amongst previously diagnosed hypertension and diabetes patients.
 
at the end of the staudy that is 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
3. Level of medication adherence pattern amongst previously diagnosed hypertension patients.
 
AT baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   23/01/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

There is a paradigm shift in the disease patterns all around the world. The last three decades have seen a rapid increase in the non-communicable disease (NCD) related morbidity and mortality. The key risk factors for developing of NCDs such as abdominal obesity, insulin resistance, hypertension and hyperlipidaemia are grouped together under the heading of metabolic syndrome. In this study we aim to do a community-based screening to estimate the prevalence of metabolic syndrome and its risk factors in a densely populated urban settlement in Delhi. The results of this study would help in understanding the difference in prevalence pattern of risk factors in community and help guide the policy making process for devising effective prevention, control and treatment strategies for metabolic syndrome.

The study will be conducted in an urban resettlement colony of Gokalpuri, which comes under the field practice area of Department of Community medicine, Maulana Azad medical College for a period of 3 months. A total of 200 participants will be selected from block B of Gokalpuri colony by systematic random sampling.

The participants selected would be interviewed through a semi-structured questionnaire and they would undergo screening and examination to evaluate the presence of Metabolic syndrome and other risk factors for developing NCDs in the future. The data will be collected using mobile application Epicollect5 and analyzed using Statistical Package for the Social Sciences (SPSS) version 25.

 
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