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Completed

NCT Number: NCT04247971

Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

The purpose of this study is to gain understanding of mechanisms whereby bariatric surgery modulates pulmonary inflammation and pulmonary microbiome composition and how these changes direct the pathobiology of human obese asthma.

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Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Asthma Subjects

  • Outpatient adults of either sex 21-60 years of age with an initial asthma diagnosis at < 12 years of age (early-onset) or >12 years of age (late-onset), as defined by the NHLBI NAEPP guidelines (17).
  • Subjects with obesity (BMI ≥ 30 kg/m2).
  • Physician diagnosis of asthma.
  • Eligible and scheduled for bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or duodenal switch) and receiving care within the Duke Health System.

FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration).

  • Relatively healthy subjects able to undergo sputum induction without complications.
  • Willing and able to give informed consent and adhere to visit/protocol schedules.
  • Read and write in English.

Non-Asthma Control Subjects

  • Outpatient adults of either sex 21-60 years of age.
  • Subjects with obesity (BMI ≥ 30).
  • Eligible and scheduled for bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or duodenal switch) at Duke Regional Hospital and receiving care at the Duke Metabolic and -Weight Loss Surgery Center.
  • Normal lung function.
  • No clinical history of atopy.
  • No significant medical or psychological issues.
  • Healthy subjects able to undergo sputum induction without complications.
  • Willing and able to give informed consent and adhere to visit/protocol schedules.
  • Read and write in English.

Exclusion criteria

  • Children < 21 years of age.
  • Inpatient status.
  • Ineligibility or not scheduled for bariatric surgery at the Duke Metabolic and Weight Loss Surgery Center.
  • 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 systemic corticosteroids within four weeks of study.
  • Smoking (tobacco, e-cigarette, vaping or inhaled drugs) history > 5 pack years or smoking or vaping within the previous six months.
  • Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded).
  • An ED visit or inpatient admission for a primary respiratory diagnosis 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.

Treatment and study plan

Blood draw

Procedure

23 ml of blood collected

Sputum Collection

Procedure

Induced sputum sample collected

Pulmonary Function Test

Procedure

Pulmonary function testing

Primary outcomes

  1. Change in leptin levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  2. Change in adiponectin levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  3. Change in IL-8 levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  4. Change in IL-6 levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  5. Change in cystatin-c levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  6. Change in IL-17 levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  7. Change in IL-1beta levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  8. Change in TNF-α levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  9. Change in YKL-40 levels

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  10. Change in lung function as measured by forced expiratory volume

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  11. Change in lung function as measured by forced vital capacity

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  12. Change in lung function as measured by fractional concentration of exhaled nitro oxide

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  13. Change in lung function as measured by FEV1/FVC

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

  14. Change in lung function as measured by forced expiratory flow

    Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2020
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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