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Selected Lysosomal Enzyme Activities and the Oxidant-antioxidant Balance in Hyperbaric Oxygen Condition.

N

Nicolaus Copernicus University

Status

Completed

Conditions

Antioxidants
Hyperbaric Oxygenation
Oxidative Stress
Oxygen Toxicity

Treatments

Procedure: Hyperbaric Oxygen Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06401941
KB 260/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Patients
Experimental group
Description:
Hyperbaric oxygen (HBO) therapy.
Treatment:
Procedure: Hyperbaric Oxygen Therapy
Controls
No Intervention group
Description:
Healthy individuals that never treated with HBO therapy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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