Hepatorenal Dysfunctions Among Workers Exposed To Petroleum Products

March 22, 2021 updated by: Shimaa Abdelsamee Mohammed Ali, Assiut University
The aim of this study is to assess the liver and renal functions of individuals who are occupationally exposed to petroleum products.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Certain peoples have a greater risk of exposure to gasoline vapors; these include filling-station workers, service station attendants, drivers of gasoline trucks and refinery workers.Benzene is metabolized in the liver by cytochrome P450 (CYP) 2E1 to benzene oxide. The metabolites undergo further metabolism through oxidation, dehydrogenation or conjugation with sulfate or glucuronic acid . Activation of benzene and its reactive metabolites leads to continuous production of reactive oxygen species (ROS), which leads to lipid peroxidation and damages DNA, RNA, leading to genetic modification and alterations in the functions of important enzymes (i.e. liver) and proteins .

Volatile organic compounds such as gasoline and other fuels are associated with a wide variety of deleterious health effects including liver and kidney diseases. A comparative cross sectional study was conducted from January 2018 to April 2018 at Mekelle city, Tigray region, Northern Ethiopia among gasoline station workers and reporting that the mean level of ALT, AST, Urea, creatinine, and uric acid was significantly higher among gasoline stations workers when compared to control study participants and there was also a significant increase in ALT, AST, Urea, creatinine and uric acid among gasoline stations with increase duration of exposure .

Study Type

Observational

Enrollment (Anticipated)

56

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 Backup

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

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

workers who are occupationally exposed to petroleum products in The Petroleum Pipelines Company in assiut.The Petroleum Pipelines Company is responsible for transporting and storing crude oil and its products and has a large network of lines.

Description

Inclusion Criteria:

for exposed group:

  • Apparently health workers who exposed for petroleum products in The Petroleum Pipelines Company in assiut will be included in the study

Exclusion Criteria:

for exposed and Comparison groups

  • history of hepatic and renal health problem
  • history of taking medications affecting liver and renal function tests

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
Intervention / Treatment
exposed group
workers in The Petroleum Pipelines Company who are occupationally exposed to petroleum products will be included in the study.
Diagnostic test: Liver function tests.
serum alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (ALB), alkaline Phosphatase (ALP), total bilirubin.
Diagnostic test: kidney function tests
creatinine , urea and serum uric acid will be analysed in the serum.
Comparison group (control group)
healthy administrative workers in assiut university
Diagnostic test: Liver function tests.
serum alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (ALB), alkaline Phosphatase (ALP), total bilirubin.
Diagnostic test: kidney function tests
creatinine , urea and serum uric acid will be analysed in the serum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of serum alanine amino transferase (ALT) in study participants.
Time Frame: 6 months
Number of participants with abnormal findings in serum alanine amino transferase (ALT) will be reported.
6 months
measurement of serum aspartate amino transferase (AST) in study participants.
Time Frame: 6 months
Number of participants with abnormal findings in serum aspartate amino transferase (AST) will be reported.
6 months
measurement of serum total bilirubin in study participants.
Time Frame: 6 months
Number of participants with abnormal findings in serum total bilirubin will be reported.
6 months
measurement of serum albumin (ALB) in study participants.
Time Frame: 6 months
Number of participants with abnormal findings in serum albumin (ALB) will be reported.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of serum urea in study participants.
Time Frame: 6 months
Number of participants with abnormal findings in serum urea will be reported.
6 months
Measurement of serum Creatinine in study participants.
Time Frame: 6 months
Number of participants with abnormal findings in serum Creatinine will be reported.
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Hanan M. Ahmed, Prof., 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (ACTUAL)

March 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HRDs in petroleum workers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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