The Relationship Between Workplace Environment and Metabolic Syndrome in Different Industries

March 24, 2021 updated by: Mariam Roshdy Elkhayat, Assiut University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

active exposed industrial workers in selected factories

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
industrial workers
Active workers more than 1 year in petrochemical plant, fertilizer factory , electrical station and food industry
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
Other Names:
  • Occupational Physical activity
control group
office work unexposed
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
Other Names:
  • Occupational Physical activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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.
up to 12 weeks From date of randomization until the date of first documented progression

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
up to 12 weeks From date of randomization until the date of first documented progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Metabolic syndrome and work

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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