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A cross-sectional study to assess night-shift work related exposures and their association with markers of biological perturbation

A cross-sectional study to assess night-shift work related exposures and their association with markers of biological perturbation - CLOCKWORK

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43599
Enrollment
300
Registered
2015-02-02
Start date
2015-04-13
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers, circadian and biological disruption markers stress markers (cortisol) and 24-hour rhythm markers (melatonin)

Interventions

None listed

Sponsors

Universiteit Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subject is between 18 years and 65 years of age by the time of performing the screening questionnaire. - Subjects are female. - Subjects are nurse or employed in a paramedic profession. - Subjects either have not worked in a profession requiring shift work for over 5 years, just started working in night shifts (

Exclusion criteria

Exclusion criteria: - Subject is a smoker or ex-smoker for less than 6 months since baseline of study inclusion. Occasional smokers that have smoked less than 100 cigarettes in their lifetime are considered non-smokers. - Subject has a doctor diagnosed chronic disease/disorder (i.e. CVD, metabolic syndrome, diabetes). - Subject has/had cancer excluding non-melanoma skin cancer. - Subject uses beta-blockers, or melatonin supplementation. - Subject was pregnant in the last 6 months or is planning to become pregnant in the next 12 months. - Subject is in fertility treatment.;Exclusion criteria for the sub-study are the same

Design outcomes

Primary

MeasureTime frame
We will assess the following night-shift work dimensions: disturbed social pattern, behavioral changes including diet and physical activity, disturbed sleep, nutrition at night, light at night, and sun exposure. We have developed a suite of tools to measure these dimensions including traditional epidemiological methods (questionnaires and logs), objective exposure measurement devices (actimetry sensors, Psychomotor Vigilance Task (PVT) using a smartphone, and light sensors). Study parameters that will be assessed in blood are traditional circadian biomarkers (cortisol and melatonin), aspects of metabolic syndrome, expression of the known clock genes, inflammatory markers, reproductive hormones, metabolism biomarkers, complete blood counts (CBC), and vitamin D status. Urine samples will be used to assess melatonin. Primary study parameters are: * Lifestyle aspects * 24hr activity pattern * 24hr exposure pattern * 24hr dietary pattern * Sleep quality * 24hr exposure to light * Behavioral and social changes * Psychomotor Vigilance Task test * Clock gene expression in peripheral blood * Markers of metabolic syndrome in peripheral blood * Chronotype * Blood pressure * Body Mass Index * Waist circumference * Melatonin in 24hr urine * Complete blood counts (CBC, infections, immune system) In the sub-study: Primary study parameters are: * Clock gene expression in peripheral blood * Markers of metabolic syndrome in peripheral blood * Complete blood counts (CBC, infections, immune system) * Cellular biomarkers of functional response to infection in peripheral blood

Secondary

MeasureTime frame
In addition to the primary study parameters we will assess a suite of OMICs markers in the blood samples to conduct exploratory analyses of short- and long- term markers of night-shift work. The gut microbiome will be assessed in a feces sample and hair samples will be used to assess cortisol levels (secondary parameters). Secondary study parameters are: * Cortisol determined in hair sample * OMICS markers determined in blood sample * Microbiome markers determined in feces In the sub-study: In addition to the primary study parameters we will assess a suite of OMICs markers in the blood samples to conduct exploratory analyses of short- and long-term markers of night-shift work.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)