Metabolic Syndrome, Protection AgainstNCT04815538
The Relationship Between Workplace Environment and Metabolic Syndrome in Different Industries
An observational study of Metabolic Syndrome, Protection Against, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Metabolic Syndrome, Protection Against
- What is being tested?
- the subscale of Health-Promoting Lifestyle Profile II
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Adult
Study population: active exposed industrial workers in selected factories
Who may be able to join
- Active workers more than 1 year in selected plants with matched controls from employee of Assiut University.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Metabolic Syndrome, Protection Against
- Being tested
- the subscale of Health-Promoting Lifestyle Profile II
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the subscale of Health-Promoting Lifestyle Profile IIBehavioural
Also called Occupational Physical activity
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
| Study group | Role | What they receive |
|---|---|---|
| industrial workers | Active workers more than 1 year in petrochemical plant, fertilizer factory , electrical station and food industry Receives: Behavioral: the subscale of Health-Promoting Lifestyle Profile II | |
| control group | office work unexposed Receives: Behavioral: the subscale of Health-Promoting Lifestyle Profile II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 12 weeks From date of randomization until the date of first documented progression
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.
Measured: up to 12 weeks From date of randomization until the date of first documented progression
Secondary outcomes (1)
blood sample for Complete blood picture
5 ml of blood to measure WBCs derangement
Measured: up to 12 weeks From date of randomization until the date of first documented progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study startJun 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome, Protection AgainstStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815538
- Sponsor's protocol ID
- Metabolic syndrome and work
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
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.
PubMed 29061986Hidaka 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.
PubMed 27082961Jeong 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.
PubMed 30325358Clementi 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.
PubMed 30704059Mini 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.
PubMed 30033228Sajid 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.
PubMed 32831856
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Workplace Environment and Metabolic Syndrome in Different Industries
- ClinicalTrials.gov ID
- NCT04815538
- Acronym / sponsor ID
- Metabolic syndrome and work
- Conditions
- Metabolic Syndrome, Protection Against
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| industrial workers | – | Behavioral: the subscale of Health-Promoting Lifestyle Profile IIActive workers more than 1 year in petrochemical plant, fertilizer factory , electrical station and food industry |
| control group | – | Behavioral: the subscale of Health-Promoting Lifestyle Profile IIoffice work unexposed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- active exposed industrial workers in selected factories
Key inclusion criteria (1 listed)
- Active workers more than 1 year in selected plants with matched controls from employee of Assiut University.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the subscale of Health-Promoting Lifestyle Profile IIAlso: Occupational Physical activityNutritional 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 | Behavioural | control group, industrial workers |
Primary outcome
Metabolic Syndrome no. among each group
Time frame: up to 12 weeks From date of randomization until the date of first documented progression
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).
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.
1 secondary outcome
blood sample for Complete blood picture
Time frame: up to 12 weeks From date of randomization until the date of first documented progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 29061986Huang 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.
- Background: PubMed 27082961Hidaka 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.
- Background: PubMed 30325358Jeong 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.
- Background: PubMed 30704059Clementi 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.
- Background: PubMed 30033228Mini 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.
- Background: PubMed 32831856Sajid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, Protection Against, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam R Elkhayat, lecturer (+20 00201003708261, mariam.elkhayat@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome no. among each group (time frame: up to 12 weeks From date of randomization until the date of first documented progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815538, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.