Impact of Shift Work on Glucose and Lipid Metabolism of Hospital Workers (METASHIFT)

August 10, 2026 updated by: Olga Ramich (formerly Pivovarova)
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité-Universitaetsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
        • Contact:
        • Principal Investigator:
          • Claudia Spies, Prof. Dr.
        • Sub-Investigator:
          • Kathrin Scholtz, Dr. rer. medic.
      • Berlin, Germany
        • Recruiting
        • Charité - Universitätsmedizin Berlin, CharitéCentrum für Anästhesiologie und Intensivmedizin (CC 07) + CIP - Charité Intensivpflege
        • Contact:
        • Principal Investigator:
          • Enrico Schlunk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Hospital workers

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group A
Night workers
Group B
Individuals not working night shifts

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 2 weeks
Body weight [kg], as measured by scale weight
2 weeks
Body Mass Index (BMI)
Time Frame: 2 weeks
BMI [kg/m2], calculated as weight/square height
2 weeks
Blood pressure
Time Frame: 2 weeks
Systolic and diastolic blood pressure [mm Hg], as measured by manometer
2 weeks
Glycemic variability
Time Frame: 2 weeks
Inter- and intraday indices of glycemic variability assessed by CGM
2 weeks
Eating time
Time Frame: 2 weeks
Timing of all eating events [hh:mm] as assessed by food records
2 weeks
Calorie intake
Time Frame: 2 weeks
Calorie intake [kcal] as assessed by food records
2 weeks
Food composition
Time Frame: 2 weeks
Nutrient composition [EN%] as assessed by food records
2 weeks
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)
2 weeks
Objective sleep quality
Time Frame: 14 days
Sleep quality as assessed by the ActLumus device
14 days
Sleep timing
Time Frame: 14 days (sleep diary)
Sleep timing (sleep onset and offset [hh:mm]) as monitored using a sleep diary
14 days (sleep diary)
Body temperature
Time Frame: 2 weeks
Body temperature is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device
2 weeks
Light exposure
Time Frame: 2 weeks
Light exposure is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device
2 weeks
Physical activity
Time Frame: 2 weeks
Physical activity is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device
2 weeks
Concentration of liver enzymes
Time Frame: 2 weeks
γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT) and alanine aminotransferase (AST) assessed in blood plasma
2 weeks
Concentration of lipids
Time Frame: 2 weeks
Total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides assessed in blood plasma
2 weeks
Concentration of kidney parameters
Time Frame: 2 weeks
Creatinine, urea and uric acid assessed in fasting blood samples
2 weeks
Glucose concentration
Time Frame: 2 weeks
Glucose levels [mg/dl] assessed in fasting blood samples
2 weeks
HbA1C concentration
Time Frame: 2 weeks
HbA1C [%] assessed in blood samples
2 weeks
Insulin concentration
Time Frame: 2 weeks
Levels of insulin assessed using ELISA in serum samples
2 weeks
Cortisol concentration
Time Frame: 2 weeks
Levels of cortisol assessed in blood serum
2 weeks
Thyroid-stimulating hormone (TSH) concentration
Time Frame: 2 weeks
Levels of TSH assessed in blood serum
2 weeks
Leptin concentration
Time Frame: 2 weeks
Levels of leptin assessed in blood serum
2 weeks
Concentration of C-reactive protein (CRP)
Time Frame: 2 weeks
CRP assessed in blood serum
2 weeks
Concentration of interleukin-6 (IL-6)
Time Frame: 2 weeks
IL-6 assessed in blood serum
2 weeks
Gene expression in blood cells
Time Frame: 2 weeks
Whole blood transcriptome assessed by RNAseq
2 weeks
Internal circadian phase
Time Frame: 2 weeks
Circadian phase as assessed using the HairTime assay in hair samples
2 weeks
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Olga Ramich (formerly Pivovarova)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3001777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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