Shift Work and Risk of Cardio-vascular Disease

Shift-Work Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901860
• Other study ID #: 11-0725
• Status: Completed
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Shift-Work Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardio-metabolic risk	24-h ambulatory blood pressure monitoring and 3-h oral glucose tolerance test	Once
Secondary	Obesity	height, weight, BMI and waist/hip circumference and bioimpedance measurement of body fat	Once