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Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

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ClinicalTrials.gov Identifier: NCT03115632
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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).

Condition or disease
Asthma Obesity Obesity, Morbid Bariatric Surgery Candidate

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Contributing Factors in the Pathobiology of Airway Remodeling in Obesity
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : April 13, 2023
Estimated Study Completion Date : April 13, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Obese asthmatic & lean asthmatic
Obese non-asthmatic & lean non-asthmatic
Asthmatic undergoing bariatric surgery
Non-asthmatic undergoing bariatric surgery



Primary Outcome Measures :
  1. Airway fibrosis [ Time Frame: Visit 2 (14 days) ]
    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 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.

  2. Change in airway fibrosis [ Time Frame: Visit 2 (14 days), Visit 4 (1 year + 14 days) ]
    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.


Biospecimen Retention:   Samples With DNA
blood plasma, bronchoscopy with endobronchial biopsy and bronchoalveolar, RNA


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the clinics of the Duke Asthma, Allergy and Airway Center and the Duke Metabolic and Weight Loss Surgery Center, Healthy controls without lung disease will be recruited from the surrounding area
Criteria

Inclusion Criteria:

Obese asthmatic & lean asthmatic

  1. 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 NAEPP guidelines.
  2. Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 50 kg/m2
  3. Physician diagnosis of asthma
  4. FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration).
  5. Negative pregnancy test in women of childbearing potential (confirmed during screening).
  6. Relatively healthy subjects able to undergo bronchoscopy without complications.
  7. Willing and able to give informed consent and adhere to visit/protocol schedules.
  8. Read and write in English.

Obese non-asthmatic & Lean non-asthmatic

  1. Outpatient adults of either sex 18-60 years of age.
  2. Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 50 kg/m2
  3. Negative pregnancy test in women of childbearing potential (confirmed during screening).
  4. Normal lung function.
  5. No clinical history of atopy.
  6. No significant medical or psychological issues.
  7. Healthy subjects able to undergo bronchoscopy without complications.
  8. Willing and able to give informed consent and adhere to visit/protocol schedules.
  9. Read and write in English.

Asthmatic undergoing bariatric surgery

  1. 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 NAEPP guidelines.
  2. Physician diagnosis of asthma
  3. FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration).
  4. Morbidly obese subjects undergoing gastric bypass or sleeve gastrectomy and receiving care at the Duke Metabolic and Weight Loss Surgery Center.
  5. Negative pregnancy test in women of childbearing potential (confirmed during screening).
  6. Relatively healthy subjects able to undergo bronchoscopy without complications.
  7. Willing and able to give informed consent and adhere to visit/protocol schedules.
  8. Read and write in English.

Non-Asthmatic undergoing bariatric surgery

  1. Outpatient adults of either sex 18-60 years of age.
  2. Morbidly obese subjects undergoing gastric bypass or sleeve gastrectomy and receiving care at the Duke Metabolic and Weight Loss Surgery Center.
  3. Negative pregnancy test in women of childbearing potential (confirmed during screening).
  4. Normal lung function.
  5. No clinical history of atopy.
  6. No significant medical or psychological issues.
  7. Healthy subjects able to undergo bronchoscopy without complications.
  8. Willing and able to give informed consent and adhere to visit/protocol schedules.
  9. Read and write in English.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115632


Contacts
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Contact: Loretta Que, MD 919-684-8111 loretta.que@duke.edu
Contact: Erika Coleman 919-479-0861 erika.coleman@duke.edu

Locations
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United States, North Carolina
Duke Metabolic and Weight Loss Surgery Center Recruiting
Durham, North Carolina, United States, 27704
Duke Asthma Allergy and Airway Center Recruiting
Durham, North Carolina, United States, 27705
Principal Investigator: Loretta Que         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Loretta Que, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03115632     History of Changes
Other Study ID Numbers: Pro00077482
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Airway Remodeling
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathological Conditions, Anatomical