Clinical trial NCT06401941: Selected Lysosomal Enzyme Activities and the Oxidant-antioxidant Balance in Hyperbaric Oxygen Condition.
Official title: The Impact of Staying in Hyperbaric Oxygen Conditions on the Oxidant-antioxidant Balance and the Activities of Selected Lysosomal Enzymes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbaric Oxygenation
Oxygen Toxicity
Antioxidants
Oxidative Stress
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the research project was to investigate the effects of hyperbaric oxygen (HBO) treatment on the redox equilibrium in individuals with different pathological conditions. Both hyperbaric oxygenation and the pathological condition are associated with redox imbalance (oxidative stress), however, HBO is successfully used in the treatment of chronic wounds, e.g., diabetic foot syndrome, as well as in sudden and acute hearing loss, e.g., acute acoustic trauma or idiopathic sudden sensorineural hearing loss.

Detailed description: The study involed in sudden sensorineural hearing loss (SSNHL) patients, individuals with difficult-to-heal skin wounds following mechanical injuries, and diabetic foot patients. HBO therapy, which involved inhalation of 100% oxygen at a pressure of 2.5 atm, consisted of 14-30 sessions depending on the clinical case. The study material was venous blood drawn three times: before and after the first session, and after the last HBO procedure. The following variables were evaluated: the concentrations of thiobarbituric acid reactive substances (TBARS), malondialdehyde (MDA) and conjugated dienes (CD) in plasma and erythrocytes, the activities of catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidase (GPx) in erythrocytes, as well as, blood counts.

Eligibility criteria: Inclusion Criteria:

* signed informed consent form for participation in the study

Exclusion Criteria:

* other pathological conditions (disorders, wounds, diseases)
* bad feeling of the participant on the day of the study,
* refraining from smoking, drinking alcohol, and the consumption of any dietary supplements that can affect the oxidant-antioxidant balance.

Primary outcomes:
measure: Thiobarbituric acid reactive substances (TBARS)
timeFrame: Three days, three different condition measurements
measure: Malondialdehyde (MDA)
timeFrame: Three days, three different condition measurements
measure: Conjugated dienes (CD)
timeFrame: Three days, three different condition measurements
measure: Catalase (CAT)
timeFrame: Three days, three different condition measurements
measure: Superoxide dismutase (SOD)
timeFrame: Three days, three different condition measurements
measure: Glutathione peroxidase (GPx)
timeFrame: Three days, three different condition measurements
Secondary outcomes:
measure: White blood cell count (WBC)
timeFrame: Two days, two different condition measurements
measure: Red blood cell count (RBS)
timeFrame: Two days, two different condition measurements
measure: Hemoglobin (HGB)
timeFrame: Two days, two different condition measurements
measure: Hematocrit (HCT)
timeFrame: Two days, two different condition measurements
measure: Mean corpuscular volume (MCV)
timeFrame: Two days, two different condition measurements
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: Two days, two different condition measurements
measure: Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Two days, two different condition measurements
measure: Red cell distribution width (RDW)
timeFrame: Two days, two different condition measurements
measure: Platelets (PLT)
timeFrame: Two days, two different condition measurements
measure: Plateletcrit (PCT)
timeFrame: Two days, two different condition measurements
measure: Mean platelet volume (MPV)
timeFrame: Two days, two different condition measurements
measure: Platelet distribution width (PDW)
timeFrame: Two days, two different condition measurements
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland
state: Kujawsko-Pomorskie
Study officials:
affiliation: Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland
name: Paweł Sutkowy, PhD
role: PRINCIPAL_INVESTIGATOR
References: