ClinicalTrials.gg
Status unknownNCT00865293EFLUpdated Jul 14, 2009

Expiratory Airflow Limitation in Subjects With Obesity

An observational study in Obesity, sponsored by Medical Center Alkmaar. Status unknown. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-14.

Sponsored by Medical Center Alkmaar · Observational

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
30
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • expiratory flow limitation
  • EFL
  • posture
  • small airways obstruction
  • FOT
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 30 is below the median of 132 across 1,338 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Medical Center Alkmaar is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healty volunteers

Eligibility criteria

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)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)

Groups and cohorts

  • Obesity

    Subjects with obesity, defined as BMI \> 30, aged 25-60

  • Control

    Subjects with a BMI 18,5-25, aged 25-60

06

What researchers measure

Primary outcomes

  1. The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position

    Time frame: 6 months

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00865293
Lead sponsor
Medical Center Alkmaar
First posted
Mar 19, 2009
Start date
Jul 2008
Last update
Jul 14, 2009

Study contacts

J. G. van den Aardweg
study director · Medical Center Alkmaar

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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