Cardiometabolic Risk of Shiftwork

NCT ID: NCT01264913

Last Updated: 2016-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Deprivation Circadian Dysregulation Shift-Work Sleep Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Shift Workers

sleep extension & circadian alignment

Intervention Type BEHAVIORAL

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

Day Workers

sleep extension & circadian alignment

Intervention Type BEHAVIORAL

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

Interventions

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sleep 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

Intervention Type BEHAVIORAL

Other Intervention Names

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SWI intervention

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve Van Cauter

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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09-049-A

Identifier Type: -

Identifier Source: org_study_id

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