Chronic obstructive pulmonary disease (COPD) as syndrome of accelerated aging

ISRCTN	ISRCTN86049077
DOI	https://doi.org/10.1186/ISRCTN86049077
Secondary identifying numbers	3.2.09.049

Submission date: 15/03/2010
Registration date: 18/05/2010
Last edited: 18/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Erica Rutten
Scientific

Centre for Integrated Rehabilitation of Organ Failure (CIRO)
P.O. Box 4080
Horn
6080 AB
Netherlands

Email	ericarutten@ciro-horn.nl

Study information

Study design	Cross-sectional observational study with a longitudinal follow-up
Primary study design	Observational
Secondary study design	Cross-section survey
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Systemic manifestation and co-morbidity in chronic obstructive pulmonary disease (COPD) are associated with circulating markers of aging: a cross-sectional observational study with a longitudinal follow-up for two years
Study acronym	AGOPD
Study hypothesis	We hypothesise that accelerated aging is a key pathophysiological mechanism of chronic obstructive pulmonary disease (COPD), and that aging markers are related to important domains of the disease, particularly to the systemic phenotype of COPD and the clinically manifested co-morbidity.
Ethics approval(s)	Maastricht Medical Etical Commission, pending as of 16/03/2010
Condition	Chronic obstructive pulmonary disease (COPD)
Intervention	At baseline and 2 years later, the participants will be invited for two test days; one day at the Center of Expertise for Chronic Organ Failure (CIRO), Horn, and one day at the Maastricht University Medical Center (MUMC). For COPD patients, the test days will be planned before the start of the rehabilitation. The first day and after overnight fast, venous blood of about 30 ml venous blood in total will be collected, an amount which is not of clinical relevance, but the venepuncture can cause a blue spot. The electrocardiography and the pulse wave velocity will also be performed in the fasted state. During this procedure, the arm will be occluded for 5 minutes. This may give a tingling feeling, but this feeling disappears when the occlusion is removed. Dual x-ray absorptiometry scan will be performed after emptying the bladder and a lung function measurement will take place after consuming breakfast. On the second day at the MUMC, all subjects will be invited for a high resolution computed tomography (HRCT) scan of the thorax. During the follow-up of 2 years, medical status of the participants will be followed by a telephone contact every three months. For the COPD patients, lung function measurement and dual energy x-ray absorptiometry (DEXA) scan will be performed during the assessment of the rehabilitation at baseline. These tests do not have to be repeated. In a subgroup of 25 patients with the emphysema like phenotype, 25 patients with the non-emphysema like phenotype and 50 smoking healthy controls, circulating concentration of hepatokines and deoxyribonucleic acid (DNA) repair mechanism will be detected in a second venous blood sample during the second test day.
Intervention type	Other
Primary outcome measure	All analysed at baseline: 1. Markers of aging 2. Objective diagnosed co-morbidity 3. Circulating hepatokines
Secondary outcome measures	All analysed at baseline: 1. Markers of systemic inflammation and oxidative stress 2. Classic characterisation of COPD
Overall study start date	01/10/2010
Overall study end date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600
Participant inclusion criteria	COPD patients: 1. Diagnosis of COPD according to the American Thoracic Society (ATS) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (forced expiratory volume in one second [FEV1] less than 80% predicted and FEV1/forced vital capacity [FVC] less than 70% and less than 10% predicted improvement in FEV1 after Ò2-agonist inhalation 2. Both male and female, aged from 50 to 75 years 3. No respiratory tract infection or exacerbation of the disease for less than 4 weeks before the study 4. Capable of providing informed consent Healthy subjects: 1. Healthy subjects as judged by a physician 2. Without diagnosed COPD or any other described co-morbidity/chronic disease 3. Both male and female, aged from 50 to 75 years
Participant exclusion criteria	COPD patients: 1. Any kind of carcinogenic pathology less than 5 years before study participation 2. Participation in any other studies involving investigational or marketed products concomitantly or less than 4 weeks prior to entry into the study Healthy subjects: 1. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 2. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Recruitment start date	01/10/2010
Recruitment end date	01/10/2014

Locations

Countries of recruitment

Netherlands

Study participating centre

Centre for Integrated Rehabilitation of Organ Failure (CIRO)

Horn
6080 AB
Netherlands

Sponsor information

Dutch Asthma Foundation (Netherlands)
Research organisation

P.O.Box 5
Leusden
3830 AA
Netherlands

Website	http://www.astmafonds.nl
"ROR"	https://ror.org/00ddgbf74

Funders

Funder type

Research organisation

Dutch Asthma Foundation (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan