Bariatric and Obstructive Lung Disease Study II

NCT ID: NCT01127399

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bariatric, nonasthma

Participants that will have had a bariatric surgery but do not have asthma.

No interventions assigned to this group

Bariatric, asthma

Participants that will have had a bariatric surgery and have been physician diagnosed with asthma prior to the surgery.

No interventions assigned to this group

Control, nonasthma

Healthy participants that who will not be getting a bariatric surgery and who do not have asthma.

No interventions assigned to this group

Control, asthma

Healthy participants that will not be having a bariatric surgery but do have asthma.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle Clerisme-Beaty, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

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The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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K23HL097081

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00027264

Identifier Type: -

Identifier Source: org_study_id

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