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Shift Work and Risk of Cardio-vascular Disease

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ClinicalTrials.gov Identifier: NCT02901860
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this research is to test the hypothesis that those with non-traditional work schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of this research are expected to increase our understanding of physiologic tolerance to non-traditional work schedules and provide the basis for the development of methods for the early detection of adverse health effects and determine coping strategies for the millions of workers with non-traditional work schedules.

Condition or disease Intervention/treatment
Shift-Work Sleep Disorder Other: Sleep, Dietary and Cardio-metabolic Measurements

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Impact of Shift Work on Risk of Cardiovascular Disease and Diabetes: A Cross-sectional Study
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
Traditional workers
Individuals who work 'traditional" work hours, i.e., 9a-5p.
Other: Sleep, Dietary and Cardio-metabolic Measurements

At home session: 2-weeks of wrist actigraphy and sleep diaries; a food diary for the three days preceding the lab session; 24-h period of ambulatory blood pressure on a non-work day for participant. Work schedules over a 4-week period will be collected and participants identified as traditional or non-traditional workers.

Subjects will begin the stay in the research unit in the evening and will remain for about 16-20 hr. Saliva samples will be taken every 30 min from admission until bedtime. Bedtime with polysomnography will be from 11:00pm to 7:00am. Questionnaires will be administered; height, weight and waist/hip circumference and bioimpedance measurement; standard 3-h oral glucose tolerance test and blood tests (CBC, electrolytes, renal, liver and thyroid function , hemoglobin A1c, SHBG levels). For individuals with diabetes only fasting blood samples will be taken.


Non-traditional workers
Individuals who have work hours outside the usual daytime period
Other: Sleep, Dietary and Cardio-metabolic Measurements

At home session: 2-weeks of wrist actigraphy and sleep diaries; a food diary for the three days preceding the lab session; 24-h period of ambulatory blood pressure on a non-work day for participant. Work schedules over a 4-week period will be collected and participants identified as traditional or non-traditional workers.

Subjects will begin the stay in the research unit in the evening and will remain for about 16-20 hr. Saliva samples will be taken every 30 min from admission until bedtime. Bedtime with polysomnography will be from 11:00pm to 7:00am. Questionnaires will be administered; height, weight and waist/hip circumference and bioimpedance measurement; standard 3-h oral glucose tolerance test and blood tests (CBC, electrolytes, renal, liver and thyroid function , hemoglobin A1c, SHBG levels). For individuals with diabetes only fasting blood samples will be taken.





Primary Outcome Measures :
  1. cardio-metabolic risk [ Time Frame: Once ]
    24-h ambulatory blood pressure monitoring and 3-h oral glucose tolerance test


Secondary Outcome Measures :
  1. Obesity [ Time Frame: Once ]
    height, weight, BMI and waist/hip circumference and bioimpedance measurement of body fat


Biospecimen Retention:   Samples With DNA
All blood samples, with the exception of blood work which is sent to the hospital clinical labs, will be identified only with the subject study code.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers.
Criteria

Inclusion Criteria:

Age 18 and older Full-time workers- working between 7:00 a.m. and 7:00 p.m. employed full time at a medical center.

Non-traditional full-time workers- working between 7:00 a.m. and 7:00 p.m and between 7:00 p.m. and 7:00 a.m., employed full time at a medical center.

Exclusion criteria include:

Acute illness or recent change in medication. Persons employed for less than 3 months at their current job

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02901860    
Other Study ID Numbers: 11-0725
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases