Petroleum Product ToxicityNCT04815512
Hepatorenal Dysfunctions Among Workers Exposed To Petroleum Products
An observational study of Petroleum Product Toxicity, run by Assiut University.
Trial summary
The aim of this study is to assess the liver and renal functions of individuals who are occupationally exposed to petroleum products. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Petroleum Product Toxicity
- What is being tested?
- Liver function tests. and kidney function tests
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- for exposed group:
- Apparently health workers who exposed for petroleum products in The Petroleum Pipelines Company in assiut will be included in the study
Who cannot join
- for exposed and Comparison groups
- history of hepatic and renal health problem
- history of taking medications affecting liver and renal function tests
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to assess the liver and renal functions of individuals who are occupationally exposed to petroleum products.
Read the 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 .
- Conditions
- Petroleum Product Toxicity
- Being tested
- Liver function tests., kidney function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver function tests.Diagnostic test
serum alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (ALB), alkaline Phosphatase (ALP), total bilirubin.
kidney function testsDiagnostic test
creatinine , urea and serum uric acid will be analysed in the serum.
| Study group | Role | What they receive |
|---|---|---|
| exposed group | workers in The Petroleum Pipelines Company who are occupationally exposed to petroleum products will be included in the study. Receives: Diagnostic Test: Liver function tests.; Diagnostic Test: kidney function tests | |
| Comparison group (control group) | healthy administrative workers in assiut university Receives: Diagnostic Test: Liver function tests.; Diagnostic Test: kidney function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of serum alanine amino transferase (ALT) in study participants.
Number of participants with abnormal findings in serum alanine amino transferase (ALT) will be reported.
Measured: 6 months
measurement of serum aspartate amino transferase (AST) in study participants.
Number of participants with abnormal findings in serum aspartate amino transferase (AST) will be reported.
Measured: 6 months
measurement of serum total bilirubin in study participants.
Number of participants with abnormal findings in serum total bilirubin will be reported.
Measured: 6 months
measurement of serum albumin (ALB) in study participants.
Number of participants with abnormal findings in serum albumin (ALB) will be reported.
Measured: 6 months
Secondary outcomes (2)
Measurement of serum urea in study participants.
Number of participants with abnormal findings in serum urea will be reported.
Measured: 6 months
Measurement of serum Creatinine in study participants.
Number of participants with abnormal findings in serum Creatinine will be reported.
Measured: 6 months
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 startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Petroleum Product ToxicityStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Abdelsamee Mohammed Ali, Assiut University
- Investigators
- Hanan M. Ahmed, Prof., Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815512
- Sponsor's protocol ID
- HRDs in petroleum workers
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malini SS, Maithily K. Analysis of oxidative stress in chronic exposure to petroleum hydrocarbons in Karnataka,India. Asia Pac J Med Toxicol. 2017; 6(1):6-11.
Bin-Mefrij M, Alwakeel S. The effect of fuel inhalation on the kidney and liver function and blood indices in gasoline station workers. Adv Nat Appl Sci. 2017; 11(1):45-50.
Olmedo-Buenrostro BA, Ortega-Ortiz JG, Guzman-Esquivel J, Delgado-Enciso OG, Ceja-Espiritu G,Paz-Michel BA, et al. Workplace gasoline exposure increases the risk for early renal dysfunction: A case-control study in Mexico. Biomed Res. 2017; 28 (22): 9859-9863.
Asefaw T, Wolde M, Edao A, Tsegaye A, Teklu G, Tesfay F, Gebremariam G. Assessment of liver and renal function tests among gasoline exposed gas station workers in Mekelle city, Tigray region, Northern Ethiopia. PLoS One. 2020 Oct 9;15(10):e0239716. doi: 10.1371/journal.pone.0239716. eCollection 2020.
PubMed 33035217
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatorenal Dysfunctions Among Workers Exposed To Petroleum Products
- ClinicalTrials.gov ID
- NCT04815512
- Acronym / sponsor ID
- HRDs in petroleum workers
- Conditions
- Petroleum Product Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 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 aim of this study is to assess the liver and renal functions of individuals who are occupationally exposed to petroleum products.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Diagnostic Test: Liver function tests., Diagnostic Test: kidney function testsworkers in The Petroleum Pipelines Company who are occupationally exposed to petroleum products will be included in the study. |
| Comparison group (control group) | – | Diagnostic Test: Liver function tests., Diagnostic Test: kidney function testshealthy administrative workers in assiut university |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Apparently health workers who exposed for petroleum products in The Petroleum Pipelines Company in assiut will be included in the study
Key exclusion criteria (3 listed)
- for exposed and Comparison groups
- history of hepatic and renal health problem
- history of taking medications affecting liver and renal function tests
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 |
|---|---|---|
| Liver function tests.serum alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (ALB), alkaline Phosphatase (ALP), total bilirubin. | Diagnostic test | Comparison group (control group), exposed group |
| kidney function testscreatinine , urea and serum uric acid will be analysed in the serum. | Diagnostic test | Comparison group (control group), exposed group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Measurement of serum urea in study participants.
Time frame: 6 months
Measurement of serum Creatinine in study participants.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- BackgroundMalini SS, Maithily K. Analysis of oxidative stress in chronic exposure to petroleum hydrocarbons in Karnataka,India. Asia Pac J Med Toxicol. 2017; 6(1):6-11.
- BackgroundBin-Mefrij M, Alwakeel S. The effect of fuel inhalation on the kidney and liver function and blood indices in gasoline station workers. Adv Nat Appl Sci. 2017; 11(1):45-50.
- BackgroundOlmedo-Buenrostro BA, Ortega-Ortiz JG, Guzman-Esquivel J, Delgado-Enciso OG, Ceja-Espiritu G,Paz-Michel BA, et al. Workplace gasoline exposure increases the risk for early renal dysfunction: A case-control study in Mexico. Biomed Res. 2017; 28 (22): 9859-9863.
- Background: PubMed 33035217Asefaw T, Wolde M, Edao A, Tsegaye A, Teklu G, Tesfay F, Gebremariam G. Assessment of liver and renal function tests among gasoline exposed gas station workers in Mekelle city, Tigray region, Northern Ethiopia. PLoS One. 2020 Oct 9;15(10):e0239716. doi: 10.1371/journal.pone.0239716. eCollection 2020.
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.
Hanan M. Ahmed, Prof. study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Petroleum Product Toxicity, 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 2 inclusion and 3 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 25 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 Shimaa A. Mohammed, Lecturer (0201000525137, shima_dola@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of serum alanine amino transferase (ALT) in study participants. (time frame: 6 months). The study lists 4 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 NCT04815512, which also lists 4 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 25 Mar 2021.