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Multiorgan Pathology in Chronic Obstructive Pulmonary Disease (COPD)

26 maart 2010 bijgewerkt door: Top Institute Pharma

COPD: Transition of Systemic Inflammation Into Multiorgan Pathology (Study 3). (De Effecten Van Ontsteking op Skeletspieren Bij COPD)

There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. Well characterized systemic features are a chronic low grade systemic inflammation, altered body composition and a skeletal muscle fibre type shift. There are indications that an absolute or relative increase of fat mass puts COPD patients at increased risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence of osteoporosis and with impaired physical function. The origin of systemic inflammation is poorly understood. Both endogenous and exogenous risk factors contribute to systemic inflammation and extra-pulmonary manifestations of COPD.

Overall objective of study 3:

To compare the pattern and severity of the systemic inflammatory profile in relation to skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to moderate disease compared to non-susceptible smokers.

Specific objectives:

To study the relative contribution of pulmonary and extra pulmonary factors on exercise capacity, skeletal muscle function and health status
To relate diet, physical activity and cardiovascular risk factors to body composition, skeletal muscle function and exercise capacity status
To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD
To study muscle fibre type size and composition and to relate muscle oxidative phenotype with insulin sensitivity, inflammation (local and systemic) and molecular signatures of oxidative energy and protein metabolism.

Study design:

Cross-sectional study. Healthy smoking subjects and COPD patients will undergo extensive clinical, metabolic and inflammatory assessment at the university clinics in Groningen, Maastricht and CIRO Horn.

Study population:

Totally 60 subjects will be included

30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75 years)
30 COPD patients with GOLD stage II (age 40-75 years)

Studie Overzicht

Toestand

Onbekend

Conditie

Chronische obstructieve longziekte

Gedetailleerde beschrijving

Primary study parameters/outcome of the study:

Smoking history and behaviour, diet and physical activity level assessed by questionnaire
Extensive lung function and CT scanning of the lung, ECG
Candidate genes for muscle dysfunction and CVD risk
Body composition (BIA, waist-hip ratio, DEXA-scan)
Systemic inflammation
Advanced Glycosylated Endproduct (AGE)
Glucose tolerance test
Risk factors of metabolic syndrome
6 minute walking distance
Handgrip strength
Skeletal muscle function by isokinetic dynamometry
Physical activity level and pattern by accelerometry
Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

Totally 22 hours will be spend in the hospital during 3 visits
CT-scanning of the lung is associated with a radiation burden of 0.8-1.6 mSv (dependent of body weight)
50 ml peripheral blood (v. cubiti)
Muscle biopsy may be associated with temporary pain and haematoma
Drawing of arterial blood from the radial artery rarely leads to bleeding and transitory nerve damage (numb feeling in wrist/hand area).

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Nederland
- Limburg
  - Maastricht, Limburg, Nederland, 6200 MD
    - Maastricht University Medical Center, Dept. of Respiratory Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Totally 60 subjects will be included

30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years)
30 COPD patients with GOLD stage II (age 40-75 years)

Beschrijving

Inclusion Criteria:

Age 40-75 years
Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of 2 groups of table 4.3
Physically and mentally able to undergo the total study protocol
Written informed consent

Exclusion Criteria:

Participation in another study
Alpha-1-antitrypsin deficiency
Selected grade 1-3 co-morbidity listed in the ACE-27
Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
Active extra-pulmonary infection like hepatitis A-C, cystitis, gastroenteritis etc.
Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis, asthma
Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukemia etc.
Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, methotrexate, azathioprine, sintrom tablets, askal
Antibiotic or prednisolon use in the past 2 months

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
1 • 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years)
2 • 30 COPD patients with GOLD stage II (age 40-75 years)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
6 minuten loopafstand
Lichaamssamenstelling
Handgreep kracht
Smoking history and behaviour, diet and physical activity level assessed by questionnaire
Extensive lung function and CT scanning of the lung, ECG
Candidate genes for muscle dysfunction and CVD risk
Systemic inflammation
Advanced Glycosylated Endproduct (AGE)
Glucose Tolerance Test
Risk factors of metabolic syndrome
Skeletal muscle function by isokinetic dynamometry
Physical activity level and pattern by accelerometry
Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Top Institute Pharma

Medewerkers

GlaxoSmithKline

AstraZeneca

University Medical Center Groningen

Maastricht University Medical Center

UMC Utrecht

Danone Institute International

Nycomed

Onderzoekers

Hoofdonderzoeker: Emiel Wouters, Prof. dr. MD, Maastricht University Medical Center, Dept. of Respiratory Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2010

Primaire voltooiing (Verwacht)

1 april 2015

Studie voltooiing (Verwacht)