Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07426211

Impact of Shift Work on Glucose and Lipid Metabolism of Hospital Workers

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronodisruption Glucose and Lipid Metabolism Shift Work Disorder

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité-Universitaetsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean 24-hour glucose levels and mean night glucose levels

    Time frame: 2 weeks

    Mean 24-hour glucose [mg/dl] and mean night glucose [mg/dl] assessed by continuous glucose monitoring (CGM)

Secondary outcomes

  1. Body weight

    Time frame: 2 weeks

    Body weight [kg], as measured by scale weight

  2. Body Mass Index (BMI)

    Time frame: 2 weeks

    BMI [kg/m2], calculated as weight/square height

  3. Blood pressure

    Time frame: 2 weeks

    Systolic and diastolic blood pressure [mm Hg], as measured by manometer

  4. Glycemic variability

    Time frame: 2 weeks

    Inter- and intraday indices of glycemic variability assessed by CGM

  5. Eating time

    Time frame: 2 weeks

    Timing of all eating events [hh:mm] as assessed by food records

  6. Calorie intake

    Time frame: 2 weeks

    Calorie intake [kcal] as assessed by food records

  7. Food composition

    Time frame: 2 weeks

    Nutrient composition [EN%] as assessed by food records

  8. Subjective sleep quality

    Time frame: 2 weeks

    Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality)

  9. Objective sleep quality

    Time frame: 14 days

    Sleep quality as assessed by the ActLumus device

  10. Sleep timing

    Time frame: 14 days (sleep diary)

    Sleep timing (sleep onset and offset [hh:mm]) as monitored using a sleep diary

  11. Body temperature

    Time frame: 2 weeks

    Body temperature is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device

  12. Light exposure

    Time frame: 2 weeks

    Light exposure is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device

  13. Physical activity

    Time frame: 2 weeks

    Physical activity is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device

  14. Concentration of liver enzymes

    Time frame: 2 weeks

    γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT) and alanine aminotransferase (AST) assessed in blood plasma

  15. Concentration of lipids

    Time frame: 2 weeks

    Total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides assessed in blood plasma

  16. Concentration of kidney parameters

    Time frame: 2 weeks

    Creatinine, urea and uric acid assessed in fasting blood samples

  17. Glucose concentration

    Time frame: 2 weeks

    Glucose levels [mg/dl] assessed in fasting blood samples

  18. HbA1C concentration

    Time frame: 2 weeks

    HbA1C [%] assessed in blood samples

  19. Insulin concentration

    Time frame: 2 weeks

    Levels of insulin assessed using ELISA in serum samples

  20. Cortisol concentration

    Time frame: 2 weeks

    Levels of cortisol assessed in blood serum

  21. Thyroid-stimulating hormone (TSH) concentration

    Time frame: 2 weeks

    Levels of TSH assessed in blood serum

  22. Leptin concentration

    Time frame: 2 weeks

    Levels of leptin assessed in blood serum

  23. Concentration of C-reactive protein (CRP)

    Time frame: 2 weeks

    CRP assessed in blood serum

  24. Concentration of interleukin-6 (IL-6)

    Time frame: 2 weeks

    IL-6 assessed in blood serum

  25. Gene expression in blood cells

    Time frame: 2 weeks

    Whole blood transcriptome assessed by RNAseq

  26. Internal circadian phase

    Time frame: 2 weeks

    Circadian phase as assessed using the HairTime assay in hair samples

  27. Chronotype

    Time frame: 2 weeks

    Chronotype will be determined using the Munich ChronoType Questionnaire (MCTQ) , with scores ranging from 16 to 86. Lower scores indicate extreme late chronotypes, while higher scores indicate extreme early chronotypes

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Merckens

CONTACT

[email protected]

+49 33200 882459

Olga Ramich, Prof. Dr.

CONTACT

[email protected]

+49 33200 882749

Sponsors and collaborators

Lead sponsor

Olga Ramich (formerly Pivovarova)

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Acronym: METASHIFT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.