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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401941
• Other study ID #: KB 260/2016
• Status: Completed
• Phase: N/A
• Start date: April 26, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2024
• Source: Nicolaus Copernicus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antioxidants
• Hyperbaric Oxygenation
• Oxidative Stress
• Oxygen Toxicity

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thiobarbituric acid reactive substances (TBARS)	Lipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.	Three days, three different condition measurements
Primary	Malondialdehyde (MDA)	Lipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.	Three days, three different condition measurements
Primary	Conjugated dienes (CD)	Lipid peroxidation index, determined in plasma and erythrocytes.	Three days, three different condition measurements
Primary	Catalase (CAT)	Antioxidant enzyme, determined in erythrocytes.	Three days, three different condition measurements
Primary	Superoxide dismutase (SOD)	Antioxidant enzyme, determined in erythrocytes.	Three days, three different condition measurements
Primary	Glutathione peroxidase (GPx)	Antioxidant enzyme, determined in erythrocytes.	Three days, three different condition measurements
Secondary	White blood cell count (WBC)	Leukocytes found in peripheral blood with specyfication of their types: lymphocytes, monocytes, neutrophils, eosinophils, basophils.	Two days, two different condition measurements
Secondary	Red blood cell count (RBS)	Erythrocytes found in peripheral blood.	Two days, two different condition measurements
Secondary	Hemoglobin (HGB)	Mean concentration of hemoglobin in the blood.	Two days, two different condition measurements
Secondary	Hematocrit (HCT)	The percentage of red blood cells in the blood.	Two days, two different condition measurements
Secondary	Mean corpuscular volume (MCV)	Mean volume of erythrocytes in the blood.	Two days, two different condition measurements
Secondary	Mean corpuscular hemoglobin (MCH)	Mean mass of hemoglobin in an erythrocyte.	Two days, two different condition measurements
Secondary	Mean corpuscular hemoglobin concentration (MCHC)	MCH expressed in a unit of blood volume.	Two days, two different condition measurements
Secondary	Red cell distribution width (RDW)	Differences in the volume and size of erythrocytes.	Two days, two different condition measurements
Secondary	Platelets (PLT)	Thrombocytes found in peripheral blood.	Two days, two different condition measurements
Secondary	Plateletcrit (PCT)	Volume occupied by platelets in the blood.	Two days, two different condition measurements
Secondary	Mean platelet volume (MPV)	Mean volume of thrombocytes in the blood.	Two days, two different condition measurements
Secondary	Platelet distribution width (PDW)	Measurement of platelet anisocytosis calculated from the distribution of individual platelet volumes.	Two days, two different condition measurements