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

May 2, 2024 updated by: Paweł Sutkowy, Nicolaus Copernicus University

The Impact of Staying in Hyperbaric Oxygen Conditions on the Oxidant-antioxidant Balance and the Activities of Selected Lysosomal Enzymes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Kujawsko-Pomorskie
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-092
        • Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Hyperbaric oxygen (HBO) therapy.
Procedure: Hyperbaric Oxygen Therapy
HBO session includes three 20-minute inhalations of pure oxygen in a hyperbaric chamber utilizing specially fitted face masks for each patient. The session is conducted as follows: 10 minutes compression of up to 2.5 atm (0.25 MPa), inhalation of 100% oxygen for 20 minutes, a 5-minute break in the chamber without the mask (oxygen concentration up to 23%, constant temperature (room) and humidity), again 20 minutes inhalation of 100% oxygen, another 5-minute break (the same condition), the last 20 minutes inhalation of 100% oxygen, and finally a 10-minute decompression. The total duration of the session was 90 minutes.
Other Names:
  • HBO treatment
  • Hyperbaric Oxygenation
No Intervention: Controls
Healthy individuals that never treated with HBO therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thiobarbituric acid reactive substances (TBARS)
Time Frame: Three days, three different condition measurements
Lipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.
Three days, three different condition measurements
Malondialdehyde (MDA)
Time Frame: Three days, three different condition measurements
Lipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.
Three days, three different condition measurements
Conjugated dienes (CD)
Time Frame: Three days, three different condition measurements
Lipid peroxidation index, determined in plasma and erythrocytes.
Three days, three different condition measurements
Catalase (CAT)
Time Frame: Three days, three different condition measurements
Antioxidant enzyme, determined in erythrocytes.
Three days, three different condition measurements
Superoxide dismutase (SOD)
Time Frame: Three days, three different condition measurements
Antioxidant enzyme, determined in erythrocytes.
Three days, three different condition measurements
Glutathione peroxidase (GPx)
Time Frame: Three days, three different condition measurements
Antioxidant enzyme, determined in erythrocytes.
Three days, three different condition measurements

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White blood cell count (WBC)
Time Frame: Two days, two different condition measurements
Leukocytes found in peripheral blood with specyfication of their types: lymphocytes, monocytes, neutrophils, eosinophils, basophils.
Two days, two different condition measurements
Red blood cell count (RBS)
Time Frame: Two days, two different condition measurements
Erythrocytes found in peripheral blood.
Two days, two different condition measurements
Hemoglobin (HGB)
Time Frame: Two days, two different condition measurements
Mean concentration of hemoglobin in the blood.
Two days, two different condition measurements
Hematocrit (HCT)
Time Frame: Two days, two different condition measurements
The percentage of red blood cells in the blood.
Two days, two different condition measurements
Mean corpuscular volume (MCV)
Time Frame: Two days, two different condition measurements
Mean volume of erythrocytes in the blood.
Two days, two different condition measurements
Mean corpuscular hemoglobin (MCH)
Time Frame: Two days, two different condition measurements
Mean mass of hemoglobin in an erythrocyte.
Two days, two different condition measurements
Mean corpuscular hemoglobin concentration (MCHC)
Time Frame: Two days, two different condition measurements
MCH expressed in a unit of blood volume.
Two days, two different condition measurements
Red cell distribution width (RDW)
Time Frame: Two days, two different condition measurements
Differences in the volume and size of erythrocytes.
Two days, two different condition measurements
Platelets (PLT)
Time Frame: Two days, two different condition measurements
Thrombocytes found in peripheral blood.
Two days, two different condition measurements
Plateletcrit (PCT)
Time Frame: Two days, two different condition measurements
Volume occupied by platelets in the blood.
Two days, two different condition measurements
Mean platelet volume (MPV)
Time Frame: Two days, two different condition measurements
Mean volume of thrombocytes in the blood.
Two days, two different condition measurements
Platelet distribution width (PDW)
Time Frame: Two days, two different condition measurements
Measurement of platelet anisocytosis calculated from the distribution of individual platelet volumes.
Two days, two different condition measurements

Collaborators and Investigators

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

Sponsor

Nicolaus Copernicus University

Investigators

  • Principal Investigator: Paweł Sutkowy, PhD, Department of Medical Biology and Biochemistry, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Karlowicza 24, 85-092 Bydgoszcz, Poland

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 (Actual)

April 26, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KB 260/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no individual participant data (IPD) sharing plan.

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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