Bariatric and Obstructive Lung Disease Study II (BOLD II)

January 31, 2018 updated by: Johns Hopkins University

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00027264
  • K23HL097081 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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