Impact of Shift Work on Glucose and Lipid Metabolism of Hospital Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Mean 24-hour glucose levels and mean night glucose levels
研究概览
简要总结
The aim of the study is to evaluate circadian glucose, activity and dietary rhythms, as well as metabolic and cardiovascular risk associated with night shift work, sleep quality and well-being in a cohort of hospital staff, comparing employees with night shifts to employees without night shifts.
详细描述
The parallel-arm study consists of group A of employees working night shifts and group B of employees not working night shifts. After a pre-screening and an inclusion examination, both groups attend their first visit after at least two day shifts before the start of their two-week observation phase. During the visit, anthropometric measurements are conducted, blood and hair samples are collected, and questionnaires are completed and handed out. During the observation period, the 24-hour activity and glucose rhythms of the study participants are measured and the food intake is documented. After an observation phase, group A attends a second visit after at least two night shifts, including blood and hair sample collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 67
- •Male or female
- •Currently employed
- •Body-Mass-Index (BMI) <40 kg/m2
- •Working hours ≥28 hours/week
- •Employees working night shifts (group A): (1) Working night shifts for >1 year, (2) at least two night shifts within the 2-week observation period
- •Employees not working night shifts (group B): No night shifts for >1 year
- •Capable of giving consent
- •Health insurance
- •Good knowledge of German
排除标准
- •Pregnancy and breastfeeding
- •Special diets, e.g. intermittent fasting
- •Severe acute or chronic diagnosed conditions, e.g., diabetes mellitus, liver or kidney disease (e.g., cirrhosis of the liver or kidney disease with a GFR < 60), heart attack within the last 6 months, stroke, or systemic infections; current cancer or cancer diagnosed within the last 2 years
- •Bariatric surgery
- •Hereditary or acquired blood clotting disorders
- •severe mental health conditions, e.g., substance use disorders, eating disorders, or uncontrolled depression (individual assessment by study staff, if necessary following consultation with a physician)
- •Holiday in a different time zone (≥ 2 hours time difference) one month before study participation or within the 2-week observation phase
- •Participation in another study that could influence the results of the current study
- •Specific drug therapies that could influence the study results, e.g., antidiabetic medications including GLP-1 analogs, melatonin (Individual assessment by study staff, if necessary after consultation with a physician)
- •Implanted electronic medical devices, e.g., pacemakers or neurostimulators (to be assessed on a case-by-case basis by study staff, following consultation with a physician if necessary)
- •Physical or mental difficulties in understanding and following instructions from study staff
研究组 & 干预措施
Group A
Night workers
Group B
Individuals not working night shifts
结局指标
主要结局
Mean 24-hour glucose levels and mean night glucose levels
时间窗: 2 weeks
Mean 24-hour glucose \[mg/dl\] and mean night glucose \[mg/dl\] assessed by continuous glucose monitoring (CGM)
次要结局
- Body weight(2 weeks)
- Body Mass Index (BMI)(2 weeks)
- Blood pressure(2 weeks)
- Glycemic variability(2 weeks)
- Eating time(2 weeks)
- Calorie intake(2 weeks)
- Food composition(2 weeks)
- Subjective sleep quality(2 weeks)
- Objective sleep quality(14 days)
- Sleep timing(14 days (sleep diary))
- Body temperature(2 weeks)
- Light exposure(2 weeks)
- Physical activity(2 weeks)
- Concentration of liver enzymes(2 weeks)
- Concentration of lipids(2 weeks)
- Concentration of kidney parameters(2 weeks)
- Glucose concentration(2 weeks)
- HbA1C concentration(2 weeks)
- Insulin concentration(2 weeks)
- Cortisol concentration(2 weeks)
- Thyroid-stimulating hormone (TSH) concentration(2 weeks)
- Leptin concentration(2 weeks)
- Concentration of C-reactive protein (CRP)(2 weeks)
- Concentration of interleukin-6 (IL-6)(2 weeks)
- Gene expression in blood cells(2 weeks)
- Internal circadian phase(2 weeks)
- Chronotype(2 weeks)
研究者
Olga Ramich (formerly Pivovarova)
Prof., Department Head
German Institute of Human Nutrition