ObesityBOLD IINCT01127399
Bariatric and Obstructive Lung Disease Study II
An observational study of Obesity and Asthma, run by Johns Hopkins University at 1 site in United States.
Trial summary
The prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bariatric Center at The Johns Hopkins University (Bariatric participants only), local community (Baltimore and Central Maryland area; control participants only)
Who may be able to join
- Age 18 years or older
- BMI over 35 kg/m2 (Bariatric) or BMI between 25 and 28 kg/m2 (Control)
- Physician diagnosis of asthma and on active asthma medication (if asthmatic)
Who cannot join
- Weight greater than 450 lbs
- Unstable cardiovascular disease
- Uncontrolled hypertension
- Renal failure on dialysis
- Cirrhosis
- Pregnant or lactating
Show all 9Show fewer
- Bleeding disorders or Coumadin use
- Recent hospitalization for asthma in the past 3 months
- Active smoking or more than 10 pack year smoking history
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus
Baltimore, Maryland, 21224
About this study
Official title: Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone
The prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is being done to determine how weight or body size affects airway size and airway smooth muscle (ASM) tone and function. The goal of the study will be to look at if and how, weight might affect lung functioning.
The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar to what is seen in asthma.
- Medical subject headings
- Obesity, Asthma
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 |
|---|---|---|
| Bariatric, nonasthma | Participants that will have had a bariatric surgery but do not have asthma. | |
| Bariatric, asthma | Participants that will have had a bariatric surgery and have been physician diagnosed with asthma prior to the surgery. | |
| Control, nonasthma | Healthy participants that who will not be getting a bariatric surgery and who do not have asthma. | |
| Control, asthma | Healthy participants that will not be having a bariatric surgery but do have asthma. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Funding revoked
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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Clerisme-Beaty, MD, MHS, Principal investigator, The Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127399
- Sponsor's protocol ID
- NA_00027264
- Other IDs
- K23HL097081
- Acronym
- BOLD II
- Status last verified
- Jan 2018
- First submitted
- 19 May 2010
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone
- ClinicalTrials.gov ID
- NCT01127399
- Acronym / sponsor ID
- BOLD II / NA_00027264
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding revoked
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 May 2010 (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 prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is being done to determine how weight or body size affects airway size and airway smooth muscle (ASM) tone and function. The goal of the study will be to look at if and how, weight might affect lung functioning.
The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar to what is seen in asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bariatric, nonasthma | – | –Participants that will have had a bariatric surgery but do not have asthma. |
| Bariatric, asthma | – | –Participants that will have had a bariatric surgery and have been physician diagnosed with asthma prior to the surgery. |
| Control, nonasthma | – | –Healthy participants that who will not be getting a bariatric surgery and who do not have asthma. |
| Control, asthma | – | –Healthy participants that will not be having a bariatric surgery but do have asthma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bariatric Center at The Johns Hopkins University (Bariatric participants only), local community (Baltimore and Central Maryland area; control participants only)
Key inclusion criteria (3 listed)
- Age 18 years or older
- BMI over 35 kg/m2 (Bariatric) or BMI between 25 and 28 kg/m2 (Control)
- Physician diagnosis of asthma and on active asthma medication (if asthmatic)
Key exclusion criteria (9 listed)
- Weight greater than 450 lbs
- Unstable cardiovascular disease
- Uncontrolled hypertension
- Renal failure on dialysis
- Cirrhosis
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funding revoked). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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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.
Emmanuelle Clerisme-Beaty, MD, MHS principal investigator
The Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Asthma, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Funding revoked). 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.
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 5 Feb 2018; AzTrials last refreshed its copy on 27 Oct 2026.