Cardiometabolic Risk of Shiftwork (SW)
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Purpose
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.
| Condition |
|---|
|
Sleep Deprivation Circadian Dysregulation Shift-Work Sleep Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption |
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Shift Workers |
| Day Workers |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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:
- 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)
Contacts and Locations| Contact: Lauran DeCeault | 773-834-3144 | ldeceaul@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Eve Van Cauter, PhD | |
| Principal Investigator: Eve Van Cauter, PhD | |
| Principal Investigator: | Eve Van Cauter | University of Chicago |
More Information
No publications provided
| Responsible Party: | Eve Van Cauter, Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01264913 History of Changes |
| Other Study ID Numbers: | 09-049-A |
| Study First Received: | December 13, 2010 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sleep Disorders, Circadian Rhythm Sleep Deprivation Sleep Disorders Parasomnias Chronobiology Disorders Dyssomnias |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Occupational Diseases |
ClinicalTrials.gov processed this record on May 19, 2013