Bariatric and Obstructive Lung Disease Study II (BOLD II)
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Purpose
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.
| Condition |
|---|
|
Obesity Asthma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone |
Blood samples.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Bariatric Center at The Johns Hopkins University (Bariatric participants only), local community (Baltimore and Central Maryland area; control participants only)
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Weight greater than 450 lbs
- Unstable cardiovascular disease
- Uncontrolled hypertension
- Renal failure on dialysis
- Cirrhosis
- Pregnant or lactating
- Bleeding disorders or Coumadin use
- Recent hospitalization for asthma in the past 3 months
- Active smoking or more than 10 pack year smoking history
Contacts and Locations| United States, Maryland | |
| The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus | |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Emmanuelle Clerisme-Beaty, MD, MHS | The Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Emmanuelle Clerisme-Beaty, MD, MHS, The Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01127399 History of Changes |
| Other Study ID Numbers: | NA_00027264, K23HL097081 |
| Study First Received: | May 19, 2010 |
| Last Updated: | June 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Asthma Obesity Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013