| CTRI Number |
CTRI/2022/06/043213 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
10/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Risk Assessment of Type 2 Diabetes Mellitus & Associated Risk Factors in
Working Women in District Gurugram, Haryana |
|
Scientific Title of Study
|
Risk Assessment of Type 2 Diabetes Mellitus & Associated Risk Factors in
Working Women in District Gurugram, Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Suri |
| Designation |
Research Scholar |
| Affiliation |
G D Goenka University |
| Address |
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Gurgaon
HARYANA
122103
India |
| Phone |
09810168422 |
| Fax |
|
| Email |
monika.suri@gdgu.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payal Mahajan |
| Designation |
Associate Professor |
| Affiliation |
G D Goenka University |
| Address |
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Gurgaon
HARYANA
122103
India |
| Phone |
08076962480 |
| Fax |
|
| Email |
payal.mahajan@gdgoenka.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Monika Suri |
| Designation |
Research Scholar |
| Affiliation |
G D Goenka University |
| Address |
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Gurgaon
HARYANA
122103
India |
| Phone |
09810168422 |
| Fax |
|
| Email |
monika.suri@gdgu.org |
|
|
Source of Monetary or Material Support
|
| G D Goenka University, Gurgaon |
|
|
Primary Sponsor
|
| Name |
Monika Suri |
| Address |
G D Goneka University, G D Goenka Education city, Gurgaon |
| 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 |
| Monika Suri |
G D Goenka University |
Department of nutrition and health,
B Block, 4th floor
G D Goenka University,
G D Goenka education city,
sohna- Gurgaon
Gurgaon
HARYANA |
09810168422
monika.suri@gdgu.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Research Ethics Committee- SOMAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
at risk of diabetes |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
25-40 year females with no history of diagnosed diabetes mellitus |
|
| ExclusionCriteria |
| Details |
females with prior medical history of diabetes mellitus, mentally ill, pregnant, lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| diabetes risk, truncal obesity, obesity |
diabetes risk ( Indian diabetes risk score), truncal obesity(waist circumference), obesity (BMI) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical activity. family history of diabetes |
Physical activity ( Indian diabetes risk score), family history of diabetes (Indian diabetes risk score) |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
15/06/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The cross-sectional observation study is aimed to screen the working women (25-40 years) for the risk of diabetes. Anthropometric data would be collected along with the risk assessment using Indian Diabetes Risk Score tool. The observations thus received would be classifed into risk categories. The subjects would also be assessed for truncal obesity and BMI. The subjects falling in high risk category would be informed on lifestyle modification. The study would thus help to achieve situational analysis of risk of diabetes among working women in given age bracket |