- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815538
The Relationship Between Workplace Environment and Metabolic Syndrome in Different Industries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Metabolic syndrome (MetS), an important risk factor for Cardio Vascular Disease (CVD), is associated with a 2-fold increase in consequences of CVD and 1.5-fold increase in the total mortality . The term MetS refers to a clustering of CVD risk factors including abdominal obesity, high blood pressure, high blood glucose, high levels of blood triglycerides, and low levels of high-density lipoprotein (HDL) cholesterol. An inappropriate lifestyle is one of the most important risk factors for MetS and CVD . Likely, Workplace and working conditions can affect an employee's lifestyle including dietary intake, physical activity, sleep pattern, and their hobbies.
Workplace environment may also affect the occurrence of metabolic syndrome, Air pollution is another risk factor that can increase the risk of metabolic disorders. Recent epidemiological and experimental studies have reported an association between increased level of air pollution with insulin resistance, weight gain, and obesity . Air pollution is higher in some industrial work environments, including those of the gas and petrochemical industries. This may also increase the risk of MetS and CVD among employees of those workplaces. Few studies have assessed the health of employees in industrial workplaces. However, the working conditions of industrial workplace can have a significant impact on the lifestyle and health of employees.
The prevalence of metabolic syndrome has recently been suggested to vary greatly depending on the subject's business category; high prevalence of metabolic syndrome has been reported among the retired, unemployed, bus drivers, university employees, and workers in the agricultural industry , oil industry , and health care sector .
Type of occupation is also important in development of metabolic syndrome. For example, the incidence of metabolic syndrome in the white-collar workers are higher than other male workers. Those with sedentary or shift work carry a higher risk of metabolic syndrome. The incidence of metabolic syndrome is 2.3-fold higher in those working for 10 or more hours per day.
Multiple studies have linked benzene exposure with the abnormality of hematologic parameters, such as the reduction in the counts of white blood cell (WBC), red blood cell (RBC), neutrophil, and lymphocyte, even at low exposure levels (< 1 ppm). A decreased WBC count has been considered as a key clinical sign of benzene-induced hematotoxicity.
However, studies investigating the relationship between work environment and metabolic syndrome in our region are scarce. We therefore, conducted this study to determine the relationship between work environment and metabolic syndrome among a petrochemical workers & non industrial workers.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Active workers more than 1 year in selected plants with matched controls from employee of Assiut University.
Exclusion Criteria:
- Workers who had been working for less than 1 year in their petrochemical plants
- Workers with self-reported and/or diagnosed carcinomas, hematological diseases, and/or immune diseases.
- Workers taking any medicine in the preceding 2 weeks affecting lipid profile & blood picture.
- Workers unwilling to provide biological samples or doing so in insufficient volume.
- Workers diagnosed MetS and its components before joing the petrochemical industry.
- Workers with morbid obesity BMI > 40
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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industrial workers
Active workers more than 1 year in petrochemical plant, fertilizer factory , electrical station and food industry
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Nutritional health behavior included the following nine items: "choose a low-fat diet"; "limit the use of sugars"; "eat servings of bread, cereal, and rice"; "eat servings of fruit"; "eat servings of vegetables"; "eat servings of meat, poultry, fish, dietary guidelines
Other Names:
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control group
office work unexposed
|
Nutritional health behavior included the following nine items: "choose a low-fat diet"; "limit the use of sugars"; "eat servings of bread, cereal, and rice"; "eat servings of fruit"; "eat servings of vegetables"; "eat servings of meat, poultry, fish, dietary guidelines
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic Syndrome no. among each group
Time Frame: up to 12 weeks From date of randomization until the date of first documented progression
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MetS was defined according to International Diabetes Federation criteria as: central obesity (defined as waist circumference 90 cm for men and 80 cm for women, plus any two of the following four factors: Raised TG level (150 mg/dl or on treatment for lipid abnormality), reduced HDL cholesterol (¼90 cm for men and >¼80 cm for women and any two of the following four factors: triglycerides >¼150 mg/ dl, reduced HDL cholesterol (<40 mg/dl in men and <50 mg/dl in women or on treatment for lipid abnormality), raised blood pressure (systolic blood pressure 130 mm Hg or diastolic blood pressure 85 mm Hg or on treatment for hypertension),raised fasting plasma glucose (FPG) (FPG100 mg/dl or on treatment for diabetes).
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up to 12 weeks From date of randomization until the date of first documented progression
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Nutritional health behavior
Time Frame: up to 12 weeks From date of randomization until the date of first documented progression
|
nutritional health behavior was obtained using the subscale of Health-Promoting Lifestyle Profile II.
Nutritional health behavior included the following nine items: "choose a low-fat diet"; "limit the use of sugars"; "eat servings of bread, cereal, and rice"; "eat servings of fruit"; "eat servings of vegetables"; "eat servings of meat, poultry, fish, dried beans, eggs and nuts"; "eat servings of milk, yogurt or cheese"; "read labels to identify nutrients"; and "eat breakfast."
The number of daily servings for each food group was set according to the dietary guidelines, Participants were asked to rate nine items on a four-point Likert scale, ranging from 1 (never) to 4 (routinely).
A higher mean score indicated a greater level of participation in nutritional health behavior.
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up to 12 weeks From date of randomization until the date of first documented progression
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood sample for Complete blood picture
Time Frame: up to 12 weeks From date of randomization until the date of first documented progression
|
5 ml of blood to measure WBCs derangement
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up to 12 weeks From date of randomization until the date of first documented progression
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Huang JH, Li RH, Huang SL, Sia HK, Lee SS, Wang WH, Tang FC. Relationships between different types of physical activity and metabolic syndrome among Taiwanese workers. Sci Rep. 2017 Oct 23;7(1):13735. doi: 10.1038/s41598-017-13872-5.
- Hidaka T, Hayakawa T, Kakamu T, Kumagai T, Hiruta Y, Hata J, Tsuji M, Fukushima T. Prevalence of Metabolic Syndrome and Its Components among Japanese Workers by Clustered Business Category. PLoS One. 2016 Apr 15;11(4):e0153368. doi: 10.1371/journal.pone.0153368. eCollection 2016.
- Jeong HS. The Relationship between Workplace Environment and Metabolic Syndrome. Int J Occup Environ Med. 2018 Oct;9(4):176-183. doi: 10.15171/ijoem.2018.1346.
- Clementi EA, Talusan A, Vaidyanathan S, Veerappan A, Mikhail M, Ostrofsky D, Crowley G, Kim JS, Kwon S, Nolan A. Metabolic Syndrome and Air Pollution: A Narrative Review of Their Cardiopulmonary Effects. Toxics. 2019 Jan 30;7(1):6. doi: 10.3390/toxics7010006.
- Mini GK, Sarma PS, Thankappan KR. Overweight, the major determinant of metabolic syndrome among industrial workers in Kerala, India: Results of a cross-sectional study. Diabetes Metab Syndr. 2019 Sep-Oct;13(5):3025-3030. doi: 10.1016/j.dsx.2018.07.009. Epub 2018 Jul 17.
- Sajid Jabbar A, Ali ET. Impact of Petroleum Exposure on Some Hematological Indices, Interleukin-6, and Inflammatory Markers of Workers at Petroleum Stations in Basra City. J Environ Public Health. 2020 Aug 4;2020:7693891. doi: 10.1155/2020/7693891. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- Metabolic syndrome and work
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