- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864994
Multiorgan Pathology in Chronic Obstructive Pulmonary Disease (COPD)
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)
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: AMWJ Schols, Prof. dr. ir.
- Phone Number: +31 43 387 5046
- Email: a.schols@pul.unimaas.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6200 MD
- Maastricht University Medical Center, Dept. of Respiratory Medicine
-
Contact:
- Annemie Schols, Prof. dr. ir.
- Phone Number: +31 43 387 50 46
- Email: a.schols@pul.unimaas.nl
-
Principal Investigator:
- Emiel Wouters, Prof. dr. MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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)
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
6 minutes walking distance
|
Body composition
|
Handgrip strength
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emiel Wouters, Prof. dr. MD, Maastricht University Medical Center, Dept. of Respiratory Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23475
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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