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临床试验/NCT06401941
NCT06401941已完成不适用

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

Nicolaus Copernicus University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2016年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
Thiobarbituric acid reactive substances (TBARS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • signed informed consent form for participation in the study

排除标准

  • 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.

结局指标

主要结局

Thiobarbituric acid reactive substances (TBARS)

时间窗: Three days, three different condition measurements

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

Conjugated dienes (CD)

时间窗: Three days, three different condition measurements

Lipid peroxidation index, determined in plasma and erythrocytes.

Catalase (CAT)

时间窗: Three days, three different condition measurements

Antioxidant enzyme, determined in erythrocytes.

Superoxide dismutase (SOD)

时间窗: Three days, three different condition measurements

Antioxidant enzyme, determined in erythrocytes.

Glutathione peroxidase (GPx)

时间窗: Three days, three different condition measurements

Antioxidant enzyme, determined in erythrocytes.

Malondialdehyde (MDA)

时间窗: Three days, three different condition measurements

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

次要结局

  • 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)
  • White blood cell count (WBC)(Two days, two different condition measurements)
  • Mean corpuscular volume (MCV)(Two days, two different condition measurements)
  • Mean corpuscular hemoglobin (MCH)(Two days, two different condition measurements)
  • Mean corpuscular hemoglobin concentration (MCHC)(Two days, two different condition measurements)
  • Red cell distribution width (RDW)(Two days, two different condition measurements)
  • Platelets (PLT)(Two days, two different condition measurements)
  • Plateletcrit (PCT)(Two days, two different condition measurements)
  • Platelet distribution width (PDW)(Two days, two different condition measurements)
  • Mean platelet volume (MPV)(Two days, two different condition measurements)

研究者

发起方
Nicolaus Copernicus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paweł Sutkowy

PhD, Assistant professor

Nicolaus Copernicus University

研究点 (2)

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