ObesityEFLNCT00865293
Expiratory Airflow Limitation in Subjects With Obesity
An observational study of Obesity, run by Medical Center Alkmaar.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healty volunteers
Who may be able to join
- Male/female, age 25-60
- BMI (body mass index) 30-40 kg/m2
- Non or ex smokers with < 10 packyears
- Male/female, age 25-60
- BMI (body mass index) 18.5-25 kg/m2
- Non or ex smokers with <10 packyears
Who cannot join
- Asthma
- COPD (FEV1/FVC<0.70)
- Reversibility >9% in FEV1 (400 microgram salbutamol)
- Other significant neuromuscular, cardiac or lung disease
- Asthma
- COPD (FEV1/FVC<0.70)
- Other significant neuromuscular, cardiac or lung disease
- Reversibility >9% in FEV1 (400 microgram salbutamol)
About this study
Official title: 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.
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.
- Conditions
- Obesity
- Keywords
- Obesity, expiratory flow limitation, EFL, posture, small airways obstruction, FOT
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Subjects with obesity, defined as BMI > 30, aged 25-60 | |
| Control | Subjects with a BMI 18,5-25, aged 25-60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Investigators
- J. G. van den Aardweg, Study director, Medical Center Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865293
- Sponsor's protocol ID
- Obesity MCA 2009
- Acronym
- EFL
- Status last verified
- Jul 2009
- First submitted
- 18 Mar 2009
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Expiratory Flow Limitation (EFL)
- ClinicalTrials.gov ID
- NCT00865293
- Acronym / sponsor ID
- EFL / Obesity MCA 2009
- Conditions
- Obesity
- Keywords
- Obesity, expiratory flow limitation, EFL, posture, small airways obstruction, FOT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Jul 2008
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | –Subjects with obesity, defined as BMI > 30, aged 25-60 |
| Control | – | –Subjects with a BMI 18,5-25, aged 25-60 |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healty volunteers
Key inclusion criteria (6 listed)
- Male/female, age 25-60
- BMI (body mass index) 30-40 kg/m2
- Non or ex smokers with < 10 packyears
- Male/female, age 25-60
- BMI (body mass index) 18.5-25 kg/m2
Key exclusion criteria (8 listed)
- Asthma
- COPD (FEV1/FVC<0.70)
- Reversibility >9% in FEV1 (400 microgram salbutamol)
- Other significant neuromuscular, cardiac or lung disease
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position
Time frame: 6 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. G. van den Aardweg study director
Medical Center Alkmaar
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Medical Center Alkmaar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2009.