Shift Work and Risk of Cardio-vascular Disease

NCT02901860 | Completed

• 1 other identifier: 11-0725
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shift-Work Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• cardio-metabolic risk

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

  Once

Secondary Outcomes (1)

• Obesity

  Once

Study Arms (2)

Traditional workers

Individuals who work 'traditional" work hours, i.e., 9a-5p.

Other: Sleep, Dietary and Cardio-metabolic Measurements

Non-traditional workers

Individuals who have work hours outside the usual daytime period

Other: Sleep, Dietary and Cardio-metabolic Measurements

Interventions

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.

Non-traditional workers; Traditional workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

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.

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Sleep; Diet

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 2, 2023

Record last verified: 2023-06