Bariatric and Obstructive Lung Disease Study II (BOLD II)

Johns Hopkins University

Status: Terminated

Conditions: Asthma; Obesity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01127399

K23HL097081 (U.S. NIH Grant/Contract)

NA_00027264

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

Bariatric, nonasthma

Description:

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

Bariatric, asthma

Description:

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

Control, nonasthma

Description:

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

Control, asthma

Description:

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