Bariatric and Obstructive Lung Disease Study II (BOLD II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01127399
Recruitment Status : Terminated (Funding revoked)
First Posted : May 20, 2010
Last Update Posted : February 2, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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. 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 or disease
Obesity Asthma

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone
Actual Study Start Date : September 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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.

Biospecimen Retention:   Samples With DNA
Blood samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01127399

United States, Maryland
The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Emmanuelle Clerisme-Beaty, MD, MHS The Johns Hopkins University

Responsible Party: Johns Hopkins University Identifier: NCT01127399     History of Changes
Other Study ID Numbers: NA_00027264
K23HL097081 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms