Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

NCT03115632 | Completed DMC

• 1 other identifier: Pro00077482
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese \& lean asthma subjects compared to obese \& lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).

Conditions

Asthma; Obesity; Obesity, Morbid; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• Airway fibrosis

  Obese asthmatics compared to lean asthmatics, obese non-asthmatics and lean non-asthmatics: A univariate linear model will be constructed to measure the effect of leptin or GLP-1 (glucagon-like peptide-1) on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue.

  Visit 2 (14 days)

• Change in airway fibrosis

  Asthmatics undergoing bariatric surgery and non-asthmatics undergoing bariatric surgery: Each patient will serve as its own control in comparing pre- and post-operative airway fibrosis. A univariate linear model will be constructed to measure the effect of bariatric surgery on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue.

  Visit 2 (14 days), Visit 4 (1 year + 14 days)

Study Arms (4)

Obese asthmatic & lean asthmatic

men and women with asthma and either obese or lean BMI

Obese non-asthmatic & lean non-asthmatic

men and women without asthma and either obese or lean BMI

Asthmatic undergoing bariatric surgery

Obese asthmatic men and women undergoing bariatric surgery

Non-asthmatic undergoing bariatric surgery

Obese men and women undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the clinics of the Duke Asthma, Allergy and Airway Center, the Duke Metabolic and Weight Loss Surgery Center, the Duke Raleigh Weight Loss Surgery Center, and the Duke Diet and Fitness Center. Healthy controls without lung disease will be recruited from the surrounding area.

You may qualify if:

• Obese asthmatic \& lean asthmatic
• Outpatient adults of either sex 18-60 years of age with an initial asthma diagnosis at \< 12 years of age, as defined by the NHLBI National Asthma Education and Prevention Program (NAEPP) guidelines.
• Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and \< 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
• Physician diagnosis of asthma
• Forced expiratory volume at one second (FEV1) within acceptable limits (\>45% predicted before and \>55% predicted after, bronchodilator administration).
• Negative pregnancy test in women of childbearing potential (confirmed during screening).
• Relatively healthy subjects able to undergo bronchoscopy without complications.
• Willing and able to give informed consent and adhere to visit/protocol schedules.
• Read and write in English.
• Obese non-asthmatic \& Lean non-asthmatic
• Outpatient adults of either sex 18-60 years of age.
• Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and \< 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
• Negative pregnancy test in women of childbearing potential (confirmed during screening).
• Normal lung function.
• No clinical history of atopy.

You may not qualify if:

• Children \< 18 years of age.
• Adults ≥ 18 years of age with an initial asthma diagnosis at ≥ 12 years of age, as defined by the NHLBI NAEPP guidelines.
• Inpatient status.
• FEV1 is less than 45% predicted before, or less than 55% predicted after, bronchodilator administration.
• Upper or lower respiratory tract infection within one month of the study.
• Use of inhaled or systemic corticosteroids within four weeks of study.
• Use of long-acting beta-2, GLP-1 receptor agonists, or dipeptidyl peptidase-4 (DPP-4) inhibitors within two weeks of study.
• Smoking history \> 5 pack years or any cigarette use within the previous six months.
• Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded).
• Positive pregnancy test for women and/or nursing women.
• An emergency department visit or inpatient admission for a primary respiratory diagnosis or treatment with antibiotics within 60 days of enrollment.
• Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
• All patients on anticoagulants
• Uncontrolled sleep apnea
• Use of e-cigarettes or "vape" devices of any kind

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke Metabolic and Weight Loss Surgery Center

Durham, North Carolina, 27704, United States

Location

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood plasma, bronchoscopy with endobronchial biopsy and brushings, bronchoalveolar lavage, RNA

MeSH Terms

Conditions

Asthma; Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Loretta Que, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 14, 2017
• Study Start: April 9, 2018
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)