Bariatric and Obstructive Lung Disease Study II

NCT01127399 | Terminated

• 2 other identifiers: NA_00027264K23HL097081
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Asthma

Study Arms (4)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus

Baltimore, Maryland, 21224, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Obesity; Asthma

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Emmanuelle Clerisme-Beaty, MD, MHS

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

US (1)