Respiratory DiseasesNCT02406053
Oxidative Damage and Antioxidant Mechanisms in COPD
An observational study of Respiratory Diseases, run by Yuzuncu Yil University.
Trial summary
The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive pulmonary disease (COPD) [3] and obstructive… Read more about this study
- Who is it for?
- Ages 38 to 79 years
- Conditions the study is for
- Respiratory Diseases
- What is being tested?
- oxidative and antioxidant biomarkers
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 111 participants (35 females, 76 males) with OSAS (n=29), COPD (n=26) and LC (n=28), and healthy controls (n=28) were included in the study.
Who may be able to join
- Malondialdehyde (MDA), 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG), and coenzyme Q10 (CoQ10) levels were evaluated in the blood samples of patients with COPD, LC, and OSAS by high-pressure liquid chromatography method.
Who cannot join
- The diagnosis of lung cancer was based on the analysis of biopsy or cytologic specimens obtained by bronchoscopic examination, transthoracic biopsy or surgery. The patients Who hadn't have chemo or/and radiotherapy were included to the study.
- The exclusion criteria for COPD, OSAS and lung cancer were the presence of the following: history of cardiovascular disease, hypertension, diabetes mellitus, inflammatory or infectious.
About this study
Official title: Evaluation of Oxidative Damage and Antioxidant Mechanisms in COPD, Lung Cancer, and Obstructive Sleep Apnea Syndrome
The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and progression of respiratory diseases. The major exposures that cause OS can be summarized as smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall outcome of pulmonary OS is increased mortality due to increased incidence of respiratory diseases [9].
Read the detailed description
Introduction Lung is a particularly important organ because of its interface with the environment. The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and progression of respiratory diseases. The major exposures that cause OS can be summarized as smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall outcome of pulmonary OS is increased mortality due to increased incidence of respiratory diseases [9].
In OSAS, an episodic hypoxia-reoxygenation cycle occurs during intermittent nocturnal hypoxias that causes the production of reactive oxygen metabolites [10]. These metabolites are responsible for the activation of inflammatory cells in OSAS [11, 12], and their increased levels eventually cause ischemia-reperfusion injury [13], and cellular and DNA damage [14, 15]. The latter, is also a significant contributor of LC progression. The DNA damage in the presence of reactive oxygen metabolites yields carcinogenesis by several mechanisms. Some of them are single or double-stranded DNA breaks, and modifications in purines or pyrimidines. Nevertheless, OS is not the only susceptible factor for carcinogenesis, there are also many other pathological mechanisms contributing to cancer development, such as reactive nitrogen species, and involvement of mitochondrial DNA mutations [16] in inflammatory conditions. Previous studies reported that LC occurs two-to-five times higher in patients with moderate-to-severe COPD [17, 18]. OS is also the main etiological factor of COPD, which is particularly important in the acute exacerbations of the disease [19]. The parenchymal damage in COPD includes some mechanisms such as chronic inflammation, OS, deteriorations in the balance of protease and antiprotease activities, and apoptosis [20]. The major etiological factor that suspected to play role in the progression of LC in COPD is reported as chronic inflammation, which causes induction of several interleukins and cyclooxygenase-2 activity. The inflammatory micro-environment is a potential medium for contributing the neoproliferative process, which interacts with regulatory mechanism such as apoptosis and angiogenesis [21].
Some biomarkers are available for evaluating the OS in the living organisms [22]. Some of these biomarkers are malondialdehyde (MDA), 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG), and coenzyme Q10 (CoQ10). Each of these biomarkers is involved in oxidative processes. MDA is a by-product of polyunsaturated fatty acid peroxidation [23]. Lipid peroxidation is the oxidation reactions between reactive oxygen metabolites and polyunsaturated fatty acids, which eventually causes changes in the structure and permeability of lung membrane [24]. The second biomarker, 8-OHdG, is primarily involved in DNA damage. The mechanism for this damage is the guanine: cytosine to adenine: thymine transversion on DNA replication [25], which induces microsatellite instability, and abnormal apoptosis or necrosis [26]. The third biomarker is CoQ10, which is also a mediator of lipid peroxidation, and an essential cofactor in the electron-transport chain (ETC). It is also a lipophilic antioxidant component of the lipid membranes [27]. In this study.
- Conditions
- Respiratory Diseases
- Being tested
- oxidative and antioxidant biomarkers
- Keywords
- lung cancer, antioxidants, oxidative damage
- Medical subject headings
- Respiratory Tract Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxidative and antioxidant biomarkersGenetic
the oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| OSAS | Obstructive sleep apnea syndrome Receives: Genetic: oxidative and antioxidant biomarkers | |
| COPD | Chronic obstructive pulmonary disease Receives: Genetic: oxidative and antioxidant biomarkers | |
| LC | Lung cancer Receives: Genetic: oxidative and antioxidant biomarkers | |
| HC | Healthy controls Receives: Genetic: oxidative and antioxidant biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative damage by evaluating the oxidative and antioxidant biomarkers
This study aimed to evaluate the oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel Sünnetçioğlu, Yuzuncu Yil University
- Investigators
- AYSEL SUNNETCIOGLU, Phd, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406053
- Sponsor's protocol ID
- YYU-016
- Other IDs
- YYU-2015-66
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sunnetcioglu A, Alp HH, Sertogullarindan B, Balaharoglu R, Gunbatar H. Evaluation of Oxidative Damage and Antioxidant Mechanisms in COPD, Lung Cancer, and Obstructive Sleep Apnea Syndrome. Respir Care. 2016 Feb;61(2):205-11. doi: 10.4187/respcare.04209. Epub 2015 Nov 24.
PubMed 26604330
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidative Damage and Antioxidant Mechanisms in COPD, Lung Cancer, and Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02406053
- Acronym / sponsor ID
- YYU-016
- Conditions
- Respiratory Diseases
- Keywords
- lung cancer, antioxidants, oxidative damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and progression of respiratory diseases. The major exposures that cause OS can be summarized as smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall outcome of pulmonary OS is increased mortality due to increased incidence of respiratory diseases [9].
Detailed description
Introduction Lung is a particularly important organ because of its interface with the environment. The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and progression of respiratory diseases. The major exposures that cause OS can be summarized as smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall outcome of pulmonary OS is increased mortality due to increased incidence of respiratory diseases [9].
In OSAS, an episodic hypoxia-reoxygenation cycle occurs during intermittent nocturnal hypoxias that causes the production of reactive oxygen metabolites [10]. These metabolites are responsible for the activation of inflammatory cells in OSAS [11, 12], and their increased levels eventually cause ischemia-reperfusion injury [13], and cellular and DNA damage [14, 15]. The latter, is also a significant contributor of LC progression. The DNA damage in the presence of reactive oxygen metabolites yields carcinogenesis by several mechanisms. Some of them are single or double-stranded DNA breaks, and modifications in purines or pyrimidines. Nevertheless, OS is not the only susceptible factor for carcinogenesis, there are also many other pathological mechanisms contributing to cancer development, such as reactive nitrogen species, and involvement of mitochondrial DNA mutations [16] in inflammatory conditions. Previous studies reported that LC occurs two-to-five times higher in patients with moderate-to-severe COPD [17, 18]. OS is also the main etiological factor of COPD, which is particularly important in the acute exacerbations of the disease [19]. The parenchymal damage in COPD includes some mechanisms such as chronic inflammation, OS, deteriorations in the balance of protease and antiprotease activities, and apoptosis [20]. The major etiological factor that suspected to play role in the progression of LC in COPD is reported as chronic inflammation, which causes induction of several interleukins and cyclooxygenase-2 activity. The inflammatory micro-environment is a potential medium for contributing the neoproliferative process, which interacts with regulatory mechanism such as apoptosis and angiogenesis [21].
Some biomarkers are available for evaluating the OS in the living organisms [22]. Some of these biomarkers are malondialdehyde (MDA), 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG), and coenzyme Q10 (CoQ10). Each of these biomarkers is involved in oxidative processes. MDA is a by-product of polyunsaturated fatty acid peroxidation [23]. Lipid peroxidation is the oxidation reactions between reactive oxygen metabolites and polyunsaturated fatty acids, which eventually causes changes in the structure and permeability of lung membrane [24]. The second biomarker, 8-OHdG, is primarily involved in DNA damage. The mechanism for this damage is the guanine: cytosine to adenine: thymine transversion on DNA replication [25], which induces microsatellite instability, and abnormal apoptosis or necrosis [26]. The third biomarker is CoQ10, which is also a mediator of lipid peroxidation, and an essential cofactor in the electron-transport chain (ETC). It is also a lipophilic antioxidant component of the lipid membranes [27]. In this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OSAS | – | Genetic: oxidative and antioxidant biomarkersObstructive sleep apnea syndrome |
| COPD | – | Genetic: oxidative and antioxidant biomarkersChronic obstructive pulmonary disease |
| LC | – | Genetic: oxidative and antioxidant biomarkersLung cancer |
| HC | – | Genetic: oxidative and antioxidant biomarkersHealthy controls |
Who may qualify
- Ages
- 38 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 111 participants (35 females, 76 males) with OSAS (n=29), COPD (n=26) and LC (n=28), and healthy controls (n=28) were included in the study.
Key inclusion criteria (1 listed)
- Malondialdehyde (MDA), 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG), and coenzyme Q10 (CoQ10) levels were evaluated in the blood samples of patients with COPD, LC, and OSAS by high-pressure liquid chromatography method.
Key exclusion criteria (2 listed)
- The diagnosis of lung cancer was based on the analysis of biopsy or cytologic specimens obtained by bronchoscopic examination, transthoracic biopsy or surgery. The patients Who hadn't have chemo or/and radiotherapy were included to the study.
- The exclusion criteria for COPD, OSAS and lung cancer were the presence of the following: history of cardiovascular disease, hypertension, diabetes mellitus, inflammatory or infectious.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxidative and antioxidant biomarkersthe oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers. | Genetic | COPD, HC, LC, OSAS |
Primary outcome
Oxidative damage by evaluating the oxidative and antioxidant biomarkers
Time frame: 4 months
This study aimed to evaluate the oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Derived from this study: PubMed 26604330Sunnetcioglu A, Alp HH, Sertogullarindan B, Balaharoglu R, Gunbatar H. Evaluation of Oxidative Damage and Antioxidant Mechanisms in COPD, Lung Cancer, and Obstructive Sleep Apnea Syndrome. Respir Care. 2016 Feb;61(2):205-11. doi: 10.4187/respcare.04209. Epub 2015 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYSEL SUNNETCIOGLU, Phd principal investigator
Yuzuncu Yil University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Diseases, run by Yuzuncu Yil University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative damage by evaluating the oxidative and antioxidant biomarkers (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.