Bariatric and Obstructive Lung Disease Study II (BOLD II)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01127399
First received: May 19, 2010
Last updated: June 24, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Biospecimen Retention:   Samples With DNA

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
Study Population

Bariatric Center at The Johns Hopkins University (Bariatric participants only), local community (Baltimore and Central Maryland area; control participants only)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127399

Locations
United States, Maryland
The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014