Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in leptin levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in leptin levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-6 levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in YKL-40 levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-17 levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in TNF-α levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced vital capacity
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-8 levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by FEV1/FVC
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory flow
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in adiponectin levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in cystatin-c levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-1beta levels
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory volume
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by fractional concentration of exhaled nitro oxide
时间窗: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
次要结局
未报告次要终点