To investigate in COPD whether: 1. systemic inflammation and multi-organ disease is more pronounced in more severe COPD2. quadriceps oxidative capacity and fiber type I proportion is reduced, and whether age, sex, smoking, physical activity, GOLD…
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Smoking history and behaviour, diet and physical activity level assessed by
questionnaire
2. Extensive lung function and CT scanning of the lung
3. Candidate genes for muscle dysfunction and CVD risk
4. Body composition
5. Systemic inflammation
6. Risk factors of metabolic syndrome
7. AGES
8. 6 minute walking distance
9. handgrip strength
10. physical activity level by questionnaire
11. Muscle oxidative phenotype, fibre cross-sectional area and molecular
signatures obtained in vastus lateralis muscle biopsies before and after
incremental cycly ergometry
12. Skeletal muscle function by isokinetic dynamometry
13. Physical activity level and pattern by accelerometry
14. Glucose tolerance test
Secondary outcome
n.a.
Background summary
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. Endogenous risk factors such as gene polymorphisms,
ageing and neurohormonal activation will be important but have not been
investigated so far at the level of extra- pulmonary manifestations.
Study objective
To investigate in COPD whether:
1. systemic inflammation and multi-organ disease is more pronounced in more
severe COPD
2. quadriceps oxidative capacity and fiber type I proportion is reduced, and
whether age, sex, smoking, physical activity, GOLD stage, and co-morbidity
contribute to this
3. systemic and muscle inflammatory profile is associated with muscle oxidative
phenotype and insulin sensitivity
4. the emphysema phenotype affects the level of systemic inflammation and
muscular inflammatory status
5. cardiovascular risk factors are related to body composition, muscle
oxidative status and lung function
6. skeletal muscle weakness affects exercise capacity and health status also in
mild to moderate COPD.
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 burden and risks
• Totally 17 hours will be spend in the hospital during 3 visits
• Metacholine provocation and sputum induction may cause temporary
bronchoconstriction in subjects with increased hyperresponsiveness.
• CT-scanning of the lung is associated with a radiation burden of 0.8-1.6 mSv
(dependent of body weight)
• 32 ml peripheral blood (v. cubiti)
• Muscle biopsy may be associated with temporary pain and haematoma.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
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
• asthma
• Alpha-1-antitrypsin deficiency
• Selected within the red made gradation of the 1-3 co-morbidity list in the ACE-27
• Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
• Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc
• Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis
• Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc
• Medication that may affect the results of the study: NSAID*s, immunosuppressive agents like prednisolon, metotrexate, azathioprine, sintrom tablets
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23475.042.08 |
| Other | Wordt nog gedaan |