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BOLD II: Bariatric and Obstructive Lung Disease Study II

Sponsor
Johns Hopkins University (Other)
Overall Status
Terminated
CT.gov ID
NCT01127399
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
40
Enrollment
1
Location
21
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Sep 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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)

      Investigators

      • Principal Investigator: Emmanuelle Clerisme-Beaty, MD, MHS, The Johns Hopkins University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Johns Hopkins University
      ClinicalTrials.gov Identifier:
      NCT01127399
      Other Study ID Numbers:
      • NA_00027264
      • K23HL097081
      First Posted:
      May 20, 2010
      Last Update Posted:
      Feb 5, 2018
      Last Verified:
      Jan 1, 2018
      Additional relevant MeSH terms:
      Obesity

      Study Results

      No Results Posted as of Feb 5, 2018