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OpenTrials
Completed

NCT Number: NCT02901860

Shift Work and Risk of Cardio-vascular Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Sleep, Dietary and Cardio-metabolic Measurements

Other

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 outcomes

  1. cardio-metabolic risk

    Time frame: Once

    24-h ambulatory blood pressure monitoring and 3-h oral glucose tolerance test

Secondary outcomes

  1. Obesity

    Time frame: Once

    height, weight, BMI and waist/hip circumference and bioimpedance measurement of body fat

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Impact of Shift Work on Risk of Cardiovascular Disease and Diabetes: A Cross-sectional Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2016
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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