Bariatric and Obstructive Lung Disease Study II | NCT01127399

Studies
Bariatric and Obstructive Lung Disease Study II

NCT01127399

Sponsor

Johns Hopkins University

Status

Terminated

Last Update Posted

Feb 5, 2018Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Obesity
Asthma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K23HL097081	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding revoked

Expanded Access Info

Start Date

Sep 2009Actual

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 19, 2010

First Submission Date that Met QC Criteria

May 19, 2010

First Posted Date

May 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2018

Last Update Posted Date

Feb 5, 2018Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuelle Clerisme-Beaty, MD, MHS	The Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus		Baltimore	Maryland	21224	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D001249	Asthma

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided