Clinical trial NCT04815512: Hepatorenal Dysfunctions Among Workers Exposed To Petroleum Products
Official title: Hepatorenal Dysfunctions Among Workers Exposed To Petroleum Products
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Petroleum Product Toxicity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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 .

Eligibility criteria: 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

Primary outcomes:
measure: measurement of serum alanine amino transferase (ALT) in study participants.
timeFrame: 6 months
measure: measurement of serum aspartate amino transferase (AST) in study participants.
timeFrame: 6 months
measure: measurement of serum total bilirubin in study participants.
timeFrame: 6 months
measure: measurement of serum albumin (ALB) in study participants.
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of serum urea in study participants.
timeFrame: 6 months
measure: Measurement of serum Creatinine in study participants.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hanan M. Ahmed, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.