Multiorgan Pathology in Chronic Obstructive Pulmonary Disease (COPD)

NCT00864994 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2010-03-29

No results posted yet for this study

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.

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:

1. To study the relative contribution of pulmonary and extra pulmonary factors on exercise capacity, skeletal muscle function and health status
2. To relate diet, physical activity and cardiovascular risk factors to body composition, skeletal muscle function and exercise capacity status
3. To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD
4. 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)

Conditions

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER
  • Maastricht University Medical Center

    collaborator OTHER
  • UMC Utrecht

    collaborator OTHER
  • Danone Institute International

    collaborator OTHER
  • GlaxoSmithKline

    collaborator INDUSTRY
  • Nycomed

    collaborator INDUSTRY
  • AstraZeneca

    collaborator INDUSTRY
  • Top Institute Pharma

    lead OTHER

Principal Investigators

  • Emiel Wouters, Prof. dr. MD · Maastricht University Medical Center, Dept. of Respiratory Medicine

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864994 on ClinicalTrials.gov