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

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: Not yet recruiting
• Conditions: Chronodisruption; Glucose and Lipid Metabolism; Shift Work Disorder

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: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Olga Ramich, Prof. Dr.; Phone Number: +49 33200 882749; Email: olga.ramich@dife.de
• Study Contact Backup: Name: Anna Merckens; Phone Number: +49 33200 882459; Email: anna.merckens@charite.de

Study Locations

• Germany
  • Berlin, Germany
    • Charité-Universitaetsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
    • Contact: Claudia Spies, Univ.-Prof. Dr. med.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de
    • Principal Investigator: Claudia Spies, Prof. Dr.
    • Sub-Investigator: Kathrin Scholtz, Dr. rer. medic.
  • Berlin, Germany
    • Pflegebereiche CC07 Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
    • Contact: Enrico Schlunk; Phone Number: +49 30 450 577 048; Email: enrico.schlunk@charite.de
    • Principal Investigator: Enrico Schlunk

Participation Criteria

Eligibility Criteria

• 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 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; Night workers
Group B; Individuals not working night shifts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight [kg], as measured by scale weight	2 weeks
Body Mass Index (BMI)	BMI [kg/m2], calculated as weight/square height	2 weeks
Blood pressure	Systolic and diastolic blood pressure [mm Hg], as measured by manometer	2 weeks
Glycemic variability	Inter- and intraday indices of glycemic variability assessed by CGM	2 weeks
Eating time	Timing of all eating events [hh:mm] as assessed by food records	2 weeks
Calorie intake	Calorie intake [kcal] as assessed by food records	2 weeks
Food composition	Nutrient composition [EN%] as assessed by food records	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)	2 weeks
Objective sleep quality	Sleep quality as assessed by the ActLumus device	14 days
Sleep timing	Sleep timing (sleep onset and offset [hh:mm]) as monitored using a sleep diary	14 days (sleep diary)
Body temperature	Body temperature is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device	2 weeks
Light exposure	Light exposure is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device	2 weeks
Physical activity	Physical activity is monitored continuously across the entire 24-hour cycle for two weeks by an ActLumus device	2 weeks
Concentration of liver enzymes	γ-glutamyltransferase (GGT), aspartate aminotransferase (ALT) and alanine aminotransferase (AST) assessed in blood plasma	2 weeks
Concentration of lipids	Total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides assessed in blood plasma	2 weeks
Concentration of kidney parameters	Creatinine, urea and uric acid assessed in fasting blood samples	2 weeks
Glucose concentration	Glucose levels [mg/dl] assessed in fasting blood samples	2 weeks
HbA1C concentration	HbA1C [%] assessed in blood samples	2 weeks
Insulin concentration	Levels of insulin assessed using ELISA in serum samples	2 weeks
Cortisol concentration	Levels of cortisol assessed in blood serum	2 weeks
Thyroid-stimulating hormone (TSH) concentration	Levels of TSH assessed in blood serum	2 weeks
Leptin concentration	Levels of leptin assessed in blood serum	2 weeks
Concentration of C-reactive protein (CRP)	CRP assessed in blood serum	2 weeks
Concentration of interleukin-6 (IL-6)	IL-6 assessed in blood serum	2 weeks
Gene expression in blood cells	Whole blood transcriptome assessed by RNAseq	2 weeks
Internal circadian phase	Circadian phase as assessed using the HairTime assay in hair samples	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	2 weeks

Collaborators and Investigators

• Sponsor: Olga Ramich (formerly Pivovarova)
• Collaborators: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition; Lipid metabolism; Glucose metabolism; Shift work; Circadian clocks
• Other Study ID 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