COPD: Transition of systemic inflammation into multiorgan pathology (study 3).

Withdrawn

Conditions: chronic obstructive bronchitis ( COPD)
emphysema
10010613

Registration Number: NL-OMON32013

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Smoking history and behaviour, diet and physical activity level assessed by<br /><br>questionnaire<br /><br>2. Extensive lung function and CT scanning of the lung<br /><br>3. Candidate genes for muscle dysfunction and CVD risk<br /><br>4. Body composition<br /><br>5. Systemic inflammation<br /><br>6. Risk factors of metabolic syndrome<br /><br>7. AGES<br /><br>8. 6 minute walking distance<br /><br>9. handgrip strength<br /><br>10. physical activity level by questionnaire<br /><br>11. Muscle oxidative phenotype, fibre cross-sectional area and molecular<br /><br>signatures obtained in vastus lateralis muscle biopsies before and after<br /><br>incremental cycly ergometry<br /><br>12. Skeletal muscle function by isokinetic dynamometry<br /><br>13. Physical activity level and pattern by accelerometry<br /><br>14. Glucose tolerance test</p><br>

Secondary Outcome Measures