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TerminatedNCT01264913SWUpdated Oct 3, 2016

Cardiometabolic Risk of Shiftwork

An observational study in Sleep Deprivation, Circadian Dysregulation and Shift-Work Sleep Disorder, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-03.

Sponsored by University of Chicago · Observational

Why this study was terminated
impossible to retain participants in 3-year longitudinal study
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
64
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.

02

Conditions studied

  • Sleep Deprivation
  • Circadian Dysregulation
  • Shift-Work Sleep Disorder
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 64 is below the median of 114 across 215 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

We will enroll 44-46 regular day workers (work hours between 7:00 a.m. and 7:00 p.m. on all work days) and 44-46 shift workers on rotating schedules (changing shift at lease once a week and having work hours between 7:00 p.m. and 7:00 a.m. on at least 10 days per month). Both groups of subjects will work at least 30 hours per week at the University of Chicago, University of Chicago Medical Center, or other Chicago area medical center and have maintained their work schedule for at least 6 months.

Inclusion criteria

  • Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months.
  • Individuals who have been shift workers for less than 10 years; body mass index \<40 kg/m2;
  • No major illness
  • No history of psychiatric, endocrine, cardiac or sleep disorders
  • Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment.
  • Women taking oral contraceptive or hormonal replacement therapy will be included only if they plan to stay on a stable regimen throughout the study.
  • Age must be between 18 and 50 years

Exclusion criteria

Exclusion Criteria:

  • Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months.
  • Individuals who have been shift workers for more than 10 years
  • BMI>40 kg/m2
  • Individuals with a major illness (e.g. diabetes, sleep disorder)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • Shift Workers

    Behavioral: sleep extension & circadian alignment

  • Day Workers

    Behavioral: sleep extension & circadian alignment

Interventions

  • Behavioralsleep extension & circadian alignment

    Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system

    Also known as: SWI intervention

06

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01264913
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Dec 22, 2010
Start date
Aug 2009
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Oct 3, 2016

Study contacts

Eve Van Cauter
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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