Erythrocytes Membrane Stability in COPD Patients in Long-Term Home Oxygen Therapy

NCT ID: NCT02732444

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-11-30

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) patients in Long-Term Home Oxygen Therapy (LTOT) have a reduction in airflow that is not totally reversible. This obstruction may be associated with an abnormal inflammatory response of the lungs as a result of inhalation of toxic particles, particularly to cigarette smoke. Furthermore, COPD patients also present limited symptoms to physical exercise, significant extrapulmonary effects, including weight loss, nutritional abnormalities and skeletal muscle dysfunction. Hyperinflation has been identified as a major cause of dyspnea and is currently believed to be already present in the early stages of the disease, causing limitations in physical capacity. The progressive exertional dyspnea is most associated with impairment to activities of daily living, decreased quality of life and worse prognosis. Traditionally, the severity of COPD is defined by the degree of obstruction, as measured by forced expiratory volume in one second (FEV1) after bronchodilator use (post-BD) and can be classified as mild, moderate, moderately severe and very severe disease. In the group of patients with Advanced Pulmonary Disease (APD), those with partial pressure values of oxygen (PaO2) lower or equal to 55mmHg, or arterial oxygen saturation (SaO2) lower or equal to 88% in ambient air; or those with PaO2 values between 55-60 or SaO2 lower than 90%, with evidence of pulmonary hypertension or polycythemia require LTOT, over 15 hours / day, with evidence of increased survival. The aim of this study is to evaluate the erythrocyte membranes stability in COPD and APD patients in LTOT compared to healthy subjects. It is a cross-sectional, observational study with evaluation of erythrocyte membranes stability among the groups as well as lung function, physical testing, laboratory analysis, oxidative stress and quality of life questionnaires. As red blood cells are the cells responsible for the gas exchange in the lungs and peripheral tissues, and since the patients with COPD and APD have gas exchange impairment compared to the healthy group, it is expected to find a difference in erythrocyte membranes stability and levels of oxidative stress among the groups.

Detailed Description

COPD is a major cause of illness and death worldwide, representing a significant economic and social cost. In the household, it causes concern, limited social life and leisure; commits the budget and shortens life. In the professional field, reduces productivity, anticipates the retirement and results in pension payments and benefits. In the area of health system, motivates repeated calls in emergency rooms, outpatient clinics and is a frequent cause of hospitalizations, which causes high costs for government and society. Most cases can be attributed to smoke.

COPD is often developed in middle-aged smokers with long time exposure which have a variety of other diseases related to smoking or aging. COPD itself has also significant extra-pulmonary effects (systemic) that lead to comorbid conditions. Nutritional abnormalities, weight loss and skeletal muscle dysfunction are well-recognized extrapulmonary effects of COPD and patients are at high risk for myocardial infarction, osteoporosis, respiratory infection, bone fractures, depression, sleep disorders, anemia and glaucoma.

Thus, this study aims to investigate the erythrocyte membranes stability in patients with COPD compared to healthy individuals, since the loss or damage of the red blood cells may be related to worsening gas exchange of patients and caused, for example, by increased oxidative stress observed in the disease mechanism of COPD patients, especially those with advanced lung disease.

Cross-sectional, observational study, which will be compared COPD patients with Advanced Lung disease using Long-Term Home Oxygen Therapy to healthy subjects to evaluate the presence of difference in membrane stability in the red blood cells as well as differences in pulmonary function tests, physical tests, laboratory analysis and presence of oxidative stress, as well as their quality of life.

The results obtained after analysis of erythrocyte membranes stability, as well as oxidative stress and functional and laboratory tests will be correlated, both in patients with COPD Long-Term Home Oxygen Therapy as the control group in order to establish relationships between variables and also compare between groups to determine the differences among them.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD and APD patients in LTOT

• COPD and APD patients in LTOT

No interventions assigned to this group

Healthy Control

• Patients without significant cardiorespiratory disease, matched for age and body mass index with the other group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Control Group

• Patients without significant cardiorespiratory disease diagnosed, matched for age and body mass index to the group of COPD patients and APD in LTOT;
• Nonsmoker;
• Age group over 40 years old;
• Male gender;
• Acceptance to participate and agreement to sign the Informed Consent Term

2. COPD Group in LTOT

• Patients with COPD and APD in LTOT;
• Patients who do not have associated severe heart disease;
• Patients with no pulmonary exacerbations in the past four weeks;
• Male gender;
• Age group over 40 years old;
• Acceptance to participate and agreement to sign the Informed Consent Term

Exclusion Criteria

• Patients with a disability or orthopedic disfunction that unable mobility or performance of physical tests;
• Patients using lipid-lowering drugs such as statins and fibrates;
• Patients or family / guardians who refuse to sign the Informed Consent Term

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Flaviana Ferreira Gomes

Biologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flaviana Gomes

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Hospital of clinics of the federal university of uberlândia

Uberlândia, Minas Gerais, Brazil

Countries

Brazil

References

Aki H, Yamamoto M. Drug binding to human erythrocytes in the process of ionic drug-induced hemolysis. Flow microcalorimetric approaches. Biochem Pharmacol. 1991 Jan 1;41(1):133-8. doi: 10.1016/0006-2952(91)90021-v.

Reference Type: BACKGROUND

PMID: 1986737 (View on PubMed)

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

Reference Type: BACKGROUND

PMID: 7154893 (View on PubMed)

Chasis JA, Mohandas N. Erythrocyte membrane deformability and stability: two distinct membrane properties that are independently regulated by skeletal protein associations. J Cell Biol. 1986 Aug;103(2):343-50. doi: 10.1083/jcb.103.2.343.

Reference Type: BACKGROUND

PMID: 3733870 (View on PubMed)

Cooper RA. Abnormalities of cell-membrane fluidity in the pathogenesis of disease. N Engl J Med. 1977 Aug 18;297(7):371-7. doi: 10.1056/NEJM197708182970707. No abstract available.

Reference Type: BACKGROUND

PMID: 327326 (View on PubMed)

Cunha CC, Arvelos LR, Costa JO, Penha-Silva N. Effects of glycerol on the thermal dependence of the stability of human erythrocytes. J Bioenerg Biomembr. 2007 Aug;39(4):341-7. doi: 10.1007/s10863-007-9092-z. Epub 2007 Oct 5.

Reference Type: BACKGROUND

PMID: 17917799 (View on PubMed)

Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.

Reference Type: BACKGROUND

PMID: 11089981 (View on PubMed)

McNeil PL, Steinhardt RA. Loss, restoration, and maintenance of plasma membrane integrity. J Cell Biol. 1997 Apr 7;137(1):1-4. doi: 10.1083/jcb.137.1.1. No abstract available.

Reference Type: BACKGROUND

PMID: 9105031 (View on PubMed)

Montuschi P, Collins JV, Ciabattoni G, Lazzeri N, Corradi M, Kharitonov SA, Barnes PJ. Exhaled 8-isoprostane as an in vivo biomarker of lung oxidative stress in patients with COPD and healthy smokers. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1175-7. doi: 10.1164/ajrccm.162.3.2001063.

Reference Type: BACKGROUND

PMID: 10988150 (View on PubMed)

Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002 May;121(5):1434-40. doi: 10.1378/chest.121.5.1434.

Reference Type: BACKGROUND

PMID: 12006425 (View on PubMed)

Park HS, Kim SR, Lee YC. Impact of oxidative stress on lung diseases. Respirology. 2009 Jan;14(1):27-38. doi: 10.1111/j.1440-1843.2008.01447.x.

Reference Type: BACKGROUND

PMID: 19144046 (View on PubMed)

Penha-Silva N, Firmino CB, de Freitas Reis FG, da Costa Huss JC, de Souza TM, de Freitas MV, Netto RC. Influence of age on the stability of human erythrocyte membranes. Mech Ageing Dev. 2007 Jul-Aug;128(7-8):444-9. doi: 10.1016/j.mad.2007.06.007. Epub 2007 Jun 28.

Reference Type: BACKGROUND

PMID: 17681589 (View on PubMed)

Singer SJ, Nicolson GL. The fluid mosaic model of the structure of cell membranes. Science. 1972 Feb 18;175(4023):720-31. doi: 10.1126/science.175.4023.720.

Reference Type: BACKGROUND

PMID: 4333397 (View on PubMed)

Office of the Surgeon General (US); Office on Smoking and Health (US). The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK44695/

Reference Type: BACKGROUND

PMID: 20669512 (View on PubMed)

Other Identifiers

FUUberlandia 01/2016

Identifier Type: -

Identifier Source: org_study_id