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

NCT06401941 | Completed DMC

• 1 other identifier: KB 260/2016
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbaric Oxygenation; Oxygen Toxicity; Antioxidants; Oxidative Stress

Outcome Measures

Primary Outcomes (6)

• Thiobarbituric acid reactive substances (TBARS)

  Lipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.

  Three days, three different condition measurements

• Malondialdehyde (MDA)

  Lipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.

  Three days, three different condition measurements

• Conjugated dienes (CD)

  Lipid peroxidation index, determined in plasma and erythrocytes.

  Three days, three different condition measurements

• Catalase (CAT)

  Antioxidant enzyme, determined in erythrocytes.

  Three days, three different condition measurements

• Superoxide dismutase (SOD)

  Antioxidant enzyme, determined in erythrocytes.

  Three days, three different condition measurements

• Glutathione peroxidase (GPx)

  Antioxidant enzyme, determined in erythrocytes.

  Three days, three different condition measurements

Secondary Outcomes (12)

• White blood cell count (WBC)

  Two days, two different condition measurements

• Red blood cell count (RBS)

  Two days, two different condition measurements

• Hemoglobin (HGB)

  Two days, two different condition measurements

• Hematocrit (HCT)

  Two days, two different condition measurements

• Mean corpuscular volume (MCV)

  Two days, two different condition measurements

Study Arms (2)

Patients

EXPERIMENTAL

Hyperbaric oxygen (HBO) therapy.

Procedure: Hyperbaric Oxygen Therapy

Controls

NO INTERVENTION

Healthy individuals that never treated with HBO therapy.

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

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.

Also known as: HBO treatment, Hyperbaric Oxygenation

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent form for participation in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Study Sites (1)

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-092, Poland

Location

Related Publications (1)

• Sutkowy P, Paprocki J, Piechocki J, Wozniak A. The impact of hyperbaric oxygen therapy on the redox balance of patients with diabetic foot syndrome. Free Radic Res. 2024 Nov;58(11):723-732. doi: 10.1080/10715762.2024.2417286. Epub 2024 Oct 19.

  PMID: 39425927 DERIVED

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: April 26, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)