Impact of Shift Work on Glucose and Lipid Metabolism of Hospital Workers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronodisruption, Shift Work Disorder, Glucose and Lipid Metabolism. Basic parameters: 18 years — 67 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- Mean 24-hour glucose levels and mean night glucose levels [Time frame: 2 weeks]
Secondary outcome measures (12)
- Body weight [Time frame: 2 weeks]
- Body Mass Index (BMI) [Time frame: 2 weeks]
- Blood pressure [Time frame: 2 weeks]
- Glycemic variability [Time frame: 2 weeks]
- Eating time [Time frame: 2 weeks]
- Calorie intake [Time frame: 2 weeks]
- Food composition [Time frame: 2 weeks]
- Subjective sleep quality [Time frame: 2 weeks]
- Objective sleep quality [Time frame: 14 days]
- Sleep timing [Time frame: 14 days (sleep diary)]
- Body temperature [Time frame: 2 weeks]
- Light exposure [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Pregnancy and breastfeeding
- Special diets, e.g. intermittent fasting
- Severe acute or chronic illnesses, e.g. type 1 diabetes mellitus, liver or kidney disease, heart attack within the last 6 months, stroke or systemic infections, current cancer or cancer within the last 2 years
- Bariatric surgery
- Hereditary or acquired blood clotting disorders
- Severe mental illnesses, e.g. depression, addiction or eating disorders (individual assessment by study staff, if necessary after consultation with a doctor)
- 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
- Special drug therapies that could influence the study results (individual assessment by study staff, if necessary after consultation with a physician)
- Physical or mental difficulties in understanding and following instructions from study staff
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Germany · 2 centers
- Charité-Universitaetsmedizin Berlin, Department of Anesthesiology and Intensive Care Medic — Berlin
- Pflegebereiche CC07 Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum — Berlin
Identifiers
NCT: NCT07426211 · 3001777