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Respiratory DiseasesNCT02406053

Oxidative Damage and Antioxidant Mechanisms in COPD

An observational study of Respiratory Diseases, run by Yuzuncu Yil University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT02406053
Study groupRoleWhat they receive
OSASObstructive sleep apnea syndrome
Receives: Genetic: oxidative and antioxidant biomarkers
COPDChronic obstructive pulmonary disease
Receives: Genetic: oxidative and antioxidant biomarkers
LCLung cancer
Receives: Genetic: oxidative and antioxidant biomarkers
HCHealthy controls
Receives: Genetic: oxidative and antioxidant biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted2 Apr 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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)
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

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.

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