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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
apparently healthy individuals
|
|
Intervention / Comparator Agent
|
|
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. |