| CTRI Number |
CTRI/2021/03/031843 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Investigator Initiated Trial |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A scientific study to assess prevalence of metabolic syndrome (MetS) in the cisgender-heterosexual, cisgender-sexual minority, transgender-heterosexual, and transgender-sexual minority subjects. |
|
Scientific Title of Study
|
Epidemiological, cross-sectional study to assess prevalence of metabolic syndrome (MetS) in the cisgender-heterosexual, cisgender-sexual minority, transgender-heterosexual and transgender-sexual minority subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MEDIQ-ZH-2020, V1.0, 29 Sep 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Kovil |
| Designation |
Diabetologist |
| Affiliation |
Zandra Healthcare Private Limited |
| Address |
Zandra Healthcare Private Limited
D/17 Shiv Ashish SV Rd Andheri West Mumbai 400058 Maharashtra India
Mumbai (Suburban)
MAHARASHTRA
400058
India |
| Phone |
02226287242 |
| Fax |
|
| Email |
rajivrkovil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Kovil |
| Designation |
Diabetologist |
| Affiliation |
Zandra Healthcare Private Limited |
| Address |
Zandra Healthcare Private Limited
D/17 Shiv Ashish SV Rd Andheri West Mumbai 400058 Maharashtra India
Mumbai (Suburban)
MAHARASHTRA
400058
India |
| Phone |
02226287242 |
| Fax |
|
| Email |
rajivrkovil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajiv Kovil |
| Designation |
Diabetologist |
| Affiliation |
Zandra Healthcare Private Limited |
| Address |
Zandra Healthcare Private Limited
D/17 Shiv Ashish SV Rd Andheri West Mumbai 400058 Maharashtra India
Mumbai (Suburban)
MAHARASHTRA
400058
India |
| Phone |
02226287242 |
| Fax |
|
| Email |
rajivrkovil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zandra Healthcare Private Limited
D/17, Shiv Ashish, SV Rd, Andheri West, Mumbai, 400058. Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Rajiv Kovil |
| Address |
D/17, Shiv Ashish, SV Rd, Andheri West, Mumbai, 400058. Maharashtra, India |
| 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 Rajiv Kovil |
Zandra Healthcare Private Limited |
Room No:D/17, Shiv Ashish, SV Rd, Andheri West, Mumbai- 400058, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA |
02226287242
rajivrkovil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who are able and willing to give written informed consent
2. Individuals must be aged ≥18 years at the time of screening
3. Individuals who are willing to identify their gender identity and sexual orientation
4. Individuals who are willing and able to comply with scheduled visits, laboratory tests and other study procedures |
|
| ExclusionCriteria |
| Details |
1. Individuals who are unwilling to complete a survey
2. Individuals unwilling to follow the study requirements
3. Individuals who are on pharmacotherapy for individual components of MetS
4. Pregnant and lactating individuals |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the prevalence of MetS and it’s components |
Single Visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="1536"
Sample Size from India="1536"
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)
|
15/03/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is epidemiological, cross-sectional study to assess prevalence of metabolic syndrome (MetS) in the cisgender-heterosexual, cisgender-sexual minority, transgender-heterosexual, and transgender-sexual minority subjects. To determine and compare the prevalence of the MetS in the cisgender-heterosexual, cisgender-sexual minority, transgender-heterosexual and transgender-sexual minority subjects and to assess the prevalence of prediabetes, diabetes, chronic kidney disease, dyslipidemia, coronary artery disease and impact of dietary habits and lifestyle on individual components of MetS, insulin sensitivity/resistance and emotional quotient (EQ) in each subject. |