NCT07426211

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

February 12, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Shift workCircadian clocksNutritionGlucose metabolismLipid metabolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (27)

  • Body weight

    2 weeks

  • Body Mass Index (BMI)

    2 weeks

  • Blood pressure

    2 weeks

  • Glycemic variability

    2 weeks

  • Eating time

    2 weeks

  • +22 more secondary outcomes

Study Arms (2)

Group A

Night workers

Group B

Individuals not working night shifts

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital workers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Berlin, Germany

Location

Pflegebereiche CC07 Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum

Berlin, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, hair roots

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof., Department Head

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 23, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations