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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04815538
Other study ID # Metabolic syndrome and work
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2021
Est. completion date October 30, 2022

Study information

Verified date March 2021
Source Assiut University
Contact Mariam R Elkhayat, lecturer
Phone +20 00201003708261
Email mariam.elkhayat@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The prevalence of MetS and its components among industrial workers and its risk factors correlates among them and compare them with those in employees from a nonindustrial setting, and explore the influence of different industries on hematological parameters especially WBCs derangement


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 156
Est. completion date October 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Active workers more than 1 year in selected plants with matched controls from employee of Assiut University. Exclusion Criteria: 1. Workers who had been working for less than 1 year in their petrochemical plants 2. Workers with self-reported and/or diagnosed carcinomas, hematological diseases, and/or immune diseases. 3. Workers taking any medicine in the preceding 2 weeks affecting lipid profile & blood picture. 4. Workers unwilling to provide biological samples or doing so in insufficient volume. 5. Workers diagnosed MetS and its components before joing the petrochemical industry. 6. Workers with morbid obesity BMI > 40

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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, dietary guidelines

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

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). pii: E6. doi: 10.3390/toxics7010006. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic Syndrome no. among each group 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). up to 12 weeks From date of randomization until the date of first documented progression
Primary Nutritional health behavior 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. up to 12 weeks From date of randomization until the date of first documented progression
Secondary blood sample for Complete blood picture 5 ml of blood to measure WBCs derangement up to 12 weeks From date of randomization until the date of first documented progression
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