- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901860
Shift Work and Risk of Cardio-vascular Disease
Impact of Shift Work on Risk of Cardiovascular Disease and Diabetes: A Cross-sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traditional workers
Individuals who work 'traditional" work hours, i.e., 9a-5p.
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardio-metabolic risk
Time Frame: Once
|
24-h ambulatory blood pressure monitoring and 3-h oral glucose tolerance test
|
Once
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obesity
Time Frame: Once
|
height, weight, BMI and waist/hip circumference and bioimpedance measurement of body fat
|
Once
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-0725
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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