Cardiometabolic Risk of Shiftwork (SW)
This study is currently recruiting participants.
Verified January 2013 by University of Chicago
Information provided by (Responsible Party):
Eve Van Cauter, University of Chicago
First received: December 13, 2010
Last updated: January 14, 2013
Last verified: January 2013
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.
Shift-Work Sleep Disorder
||Observational Model: Case Control
Time Perspective: Cross-Sectional
||Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264913
|The University of Chicago
|Chicago, Illinois, United States, 60637 |
|Contact: Eve Van Cauter, PhD |
|Principal Investigator: Eve Van Cauter, PhD |
University of Chicago
||Eve Van Cauter
||University of Chicago
No publications provided
||Eve Van Cauter, Professor of Medicine, University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 13, 2010
||January 14, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Signs and Symptoms