Genetic Clockwork: Deciphering Circadian Rhythm-Associated Genes variations in Shift Workers and the effects of Interventions across Metabolic Syndrome Groups
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •1.Individuals with type 1 diabetes and secondary diabetes.
- •2.Pregnant individuals.
结局指标
主要结局
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.
时间窗: From baseline to end of study at | year1, year 2, year3 and year 4
次要结局
- 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.)
研究者
Dr Saurabh Srivastava
Government Institute of Medical Sciences (GIMS)