ChronodisruptionMETASHIFTNCT07426211
Impact of Shift Work on Glucose and Lipid Metabolism of Hospital Workers
An observational study of Chronodisruption and Shift Work Disorder, run by Olga Ramich (formerly Pivovarova) at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronodisruption, Shift Work Disorder, Glucose and Lipid Metabolism
- How many people
- 48 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital workers
Who may be able to join
- 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
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- Employees not working night shifts (group B): No night shifts for >1 year
- Capable of giving consent
- Health insurance
- Good knowledge of German
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, CharitéCentrum für Anästhesiologie und Intensivmedizin (CC 07) + CIP - Charité Intensivpflege
Berlin
Enrico Schlunk, +49 30 450 577 048, enrico.schlunk@charite.de
Enrico Schlunk
- Recruiting
Charité-Universitaetsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
Berlin
Claudia Spies, Univ.-Prof. Dr. med., +49 30 450 55 11 02, claudia.spies@charite.de
Claudia Spies, Prof. Dr.
About this study
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.
Read the 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.
- Keywords
- Shift work, Circadian clocks, Nutrition, Glucose metabolism, Lipid metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Night workers | |
| Group B | Individuals not working night shifts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour glucose levels and mean night glucose levels
Mean 24-hour glucose [mg/dl] and mean night glucose [mg/dl] assessed by continuous glucose monitoring (CGM)
Measured: 2 weeks
Secondary outcomes (27)
Body weight
Body weight [kg], as measured by scale weight
Measured: 2 weeks
Body Mass Index (BMI)
BMI [kg/m2], calculated as weight/square height
Measured: 2 weeks
Blood pressure
Systolic and diastolic blood pressure [mm Hg], as measured by manometer
Measured: 2 weeks
Glycemic variability
Inter- and intraday indices of glycemic variability assessed by CGM
Measured: 2 weeks
Eating time
Timing of all eating events [hh:mm] as assessed by food records
Measured: 2 weeks
Calorie intake
Calorie intake [kcal] as assessed by food records
Measured: 2 weeks
Food composition
Nutrient composition [EN%] as assessed by food records
Measured: 2 weeks
Subjective sleep quality
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)
Measured: 2 weeks
Objective sleep quality
Sleep quality as assessed by the ActLumus device
Measured: 14 days
Sleep timing
Sleep timing (sleep onset and offset [hh:mm]) as monitored using a sleep diary
Measured: 14 days (sleep diary)
Body temperature
Body temperature is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device
Measured: 2 weeks
Light exposure
Light exposure is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device
Measured: 2 weeks
Physical activity
Physical activity is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device
Measured: 2 weeks
Concentration of liver enzymes
γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT) and alanine aminotransferase (AST) assessed in blood plasma
Measured: 2 weeks
Concentration of lipids
Total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides assessed in blood plasma
Measured: 2 weeks
Concentration of kidney parameters
Creatinine, urea and uric acid assessed in fasting blood samples
Measured: 2 weeks
Glucose concentration
Glucose levels [mg/dl] assessed in fasting blood samples
Measured: 2 weeks
HbA1C concentration
HbA1C [%] assessed in blood samples
Measured: 2 weeks
Insulin concentration
Levels of insulin assessed using ELISA in serum samples
Measured: 2 weeks
Cortisol concentration
Levels of cortisol assessed in blood serum
Measured: 2 weeks
Thyroid-stimulating hormone (TSH) concentration
Levels of TSH assessed in blood serum
Measured: 2 weeks
Leptin concentration
Levels of leptin assessed in blood serum
Measured: 2 weeks
Concentration of C-reactive protein (CRP)
CRP assessed in blood serum
Measured: 2 weeks
Concentration of interleukin-6 (IL-6)
IL-6 assessed in blood serum
Measured: 2 weeks
Gene expression in blood cells
Whole blood transcriptome assessed by RNAseq
Measured: 2 weeks
Internal circadian phase
Circadian phase as assessed using the HairTime assay in hair samples
Measured: 2 weeks
Chronotype
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChronodisruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olga Ramich (formerly Pivovarova)
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor-investigator, Olga Ramich (formerly Pivovarova), German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426211
- Sponsor's protocol ID
- 3001777
- Acronym
- METASHIFT
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Shift Work on Glucose and Lipid Metabolism of Hospital Workers
- ClinicalTrials.gov ID
- NCT07426211
- Acronym / sponsor ID
- METASHIFT / 3001777
- Keywords
- Shift work, Circadian clocks, Nutrition, Glucose metabolism, Lipid metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Olga Ramich (formerly Pivovarova)University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Night workers |
| Group B | – | –Individuals not working night shifts |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital workers
Key inclusion criteria (10 listed)
- Aged between 18 and 67
- Male or female
- Currently employed
- Body-Mass-Index (BMI) <40 kg/m2
- Working hours ≥28 hours/week
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
27 secondary outcomes
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
Physical activity
Time frame: 2 weeks
Concentration of liver enzymes
Time frame: 2 weeks
Concentration of lipids
Time frame: 2 weeks
Concentration of kidney parameters
Time frame: 2 weeks
Glucose concentration
Time frame: 2 weeks
HbA1C concentration
Time frame: 2 weeks
Insulin concentration
Time frame: 2 weeks
Cortisol concentration
Time frame: 2 weeks
Thyroid-stimulating hormone (TSH) concentration
Time frame: 2 weeks
Leptin concentration
Time frame: 2 weeks
Concentration of C-reactive protein (CRP)
Time frame: 2 weeks
Concentration of interleukin-6 (IL-6)
Time frame: 2 weeks
Gene expression in blood cells
Time frame: 2 weeks
Internal circadian phase
Time frame: 2 weeks
Chronotype
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronodisruption and Shift Work Disorder, run by Olga Ramich (formerly Pivovarova) at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Ramich, Prof. Dr. (+49 33200 882749, olga.ramich@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour glucose levels and mean night glucose levels (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.