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Expiratory Airflow Limitation in Subjects With Obesity (EFL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Medical Center Alkmaar.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00865293
First received: March 18, 2009
Last updated: July 13, 2009
Last verified: July 2009

March 18, 2009
July 13, 2009
July 2008
Not Provided
The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865293 on ClinicalTrials.gov Archive Site
The capacity of FOT as a measurement tool for small airways obstruction. The effects of posture and obesity on lung volumes, diffusion capacity, air flow limitation. The effect of bronchodilation by salbutamol on posture dependent flow limitation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
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Expiratory Airflow Limitation in Subjects With Obesity
Obesity and Expiratory Flow Limitation (EFL)

The purpose of this study is to investigate posture dependent small airway obstruction in subjects with obesity, and to study the capacity of FOT as a measurement tool for small airways obstruction.

Obesity is a cause of dyspnea due to mechanical impairment of pulmonary ventilation. One of the causes of this impairment is expiratory flow limitation, which is related to decreased lung volume. As a result, obesity can cause an asthma-like symptoms. Therefore, some patients with obesity are misdiagnosed as asthma-patients, and treated with asthma medication. The effects of bronchodilators on the mechanical airway obstruction in obese subjects have not been well established.

Posture also has effect on lung volumes: they are decreased in supine position. Therefore, the interaction of obesity and supine posture might result in a larger decrease in lung volumes, and thereby a more increased airflow limitation. It has been suggested that both obesity and supine posture result in an obstruction of peripheral airways. Such an obstruction can be measured by spirometry, using the ratio of forced expiratory flow between 25 and 75% and vital capacity. This measure is highly variable, however.

The forced oscillation technique (FOT) is a non-invasive method to measure the resistance and reactant of the respiratory system. Particularly the reactance has been shown useful in the measurement of airflow limitations.

The investigators hypothesize that obesity causes a posture dependent end- expiratory airflow limitation due to a mechanical compression of lung tissue, resulting in increased resistance and reactance in the airways. Therefore, the investigators expect no protective effect of bronchodilation by salbutamol. The investigators expect that reactance measured by FOT detects differences in airflow limitation and correlates with airflow limitation as measured by spirometry.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Healty volunteers

Obesity
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  • Obesity
    Subjects with obesity, defined as BMI > 30, aged 25-60
  • Control
    Subjects with a BMI 18,5-25, aged 25-60
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
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Inclusion Criteria obese population:

  • Male/female, age 25-60
  • BMI (body mass index) 30-40 kg/m2
  • Non or ex smokers with < 10 packyears

Inclusion Criteria control population:

  • Male/female, age 25-60
  • BMI (body mass index) 18.5-25 kg/m2
  • Non or ex smokers with <10 packyears

Exclusion Criteria obese population:

  • Asthma
  • COPD (FEV1/FVC<0.70)
  • Reversibility >9% in FEV1 (400 microgram salbutamol)
  • Other significant neuromuscular, cardiac or lung disease

Exclusion Criteria control population:

  • Asthma
  • COPD (FEV1/FVC<0.70)
  • Other significant neuromuscular, cardiac or lung disease
  • Reversibility >9% in FEV1 (400 microgram salbutamol)
Both
25 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00865293
Obesity MCA 2009
No
Dr. J.G. van den Aardweg, Medical Center Alkmaar
Medical Center Alkmaar
Not Provided
Study Director: J. G. van den Aardweg Medical Center Alkmaar
Medical Center Alkmaar
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP