| CTRI Number |
CTRI/2025/10/096251 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Genetic Clockwork Deciphering Circadian Rhythm-Associated Genes variations in Shift Workers |
|
Scientific Title of Study
|
Genetic Clockwork: Deciphering Circadian Rhythm-Associated Genes variations in Shift Workers and the effects of Interventions across Metabolic Syndrome Groups |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurabh Srivastava |
| Designation |
Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Medicine
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9654233158 |
| Fax |
|
| Email |
saurabhsrivas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Medicine
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8218517253 |
| Fax |
|
| Email |
deepak.102sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Kumar |
| Designation |
In-charge Clinical Trial Unit |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Clinical Trial Unit, GIMS
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9116161133 |
| Fax |
|
| Email |
ctu.gims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical research V.Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
V.Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Saurabh Srivastava |
GIMS Hospital, Greater Noida |
Room no 10, Department of Medicine, GIMS Hospital, Government Institute of Medical Sciences, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9654233158
saurabhsrivas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Institute of Medical Sciences (GIMS) Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Working Professionals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The participant is willing to sign IEC approved Informed consent will be recruited meet the following criteria
1.Adults aged 25-65 years.
2.Representing NDW, SW, and NSW.
3.No history of sleep disorders or psychiatric conditions.
|
|
| ExclusionCriteria |
| Details |
1.Individuals with type 1 diabetes and secondary diabetes.
2.Pregnant individuals.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcomes include actionable insights into designing personalized interventions that optimize circadian alignment, potentially improving metabolic outcomes in night shift workers with specific disorders. |
From baseline to end of study at
year1, year 2, year3 and year 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the association between chronotype at morningness to eveningness preference and the severity of metabolic parameters e.g., insulin resistance, BMI, glycaemic variability in shift workers.
Helps stratify participants based on intrinsic biological clock tendencies and tailor interventions more precisely.
To evaluate the feasibility, adherence, and participant satisfaction with personalized lifestyle interventions aligned with circadian patterns over a 6-month follow-up period.
To develop and validate a composite Circadian Disruption Risk Score integrating actigraphy data, gene expression profiles, and metabolic biomarkers for predictive risk stratification in night shift workers. |
From baseline to end of study at
year1, year 2, year3 and year 4 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/11/2025 |
| 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="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Project Implementation Plan:
Ethical Approval: The
study will be started upon clearance by the institutional ethical committee
(IEC).
Participant
Categorization:
Randomly selected
participants will be categorized into three groups representing different work
schedules:
Normal Day Workers
(NDW): Individuals working regular 9-5 pm jobs.
Shift Workers (SW):
Individuals engaged in rotational shift work.
Night Shift Workers
(NSW): Individuals working night shifts.
Nature of Work
Consideration:
The nature of work,
including job roles, breaks, and work-related stress, will be assessed to
understand its impact on circadian rhythm disruptions.
Age Group:
Participants aged 25-65 will be included in the study.
Routine Tests:
All participants will
undergo following routine tests like:
Glycaemia Tests: To assess
blood glucose levels.
Insulin Tests: To measure
insulin levels.
Blood Pressure
Measurements: For hypertension assessment.
BMI Measurements: To determine
obesity status.
Lipid Panel Tests: To evaluate
lipid profiles.
Fibro
scan and Imaging: To assess liver health. |