Expiratory Airflow Limitation in Subjects With Obesity

Obesity and Expiratory Flow Limitation (EFL)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00865293

Acronym

EFL

Enrollment

Registered

2009-03-19

Start date

2008-07-31

Completion date

Unknown

Last updated

2009-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, expiratory flow limitation, EFL, posture, small airways obstruction, FOT

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position	6 months

Secondary

Measure	Time frame
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.	6 months

Outcome results