Adiposity and Airway Inflammation in HIV-Associated Airway Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV
研究概览
简要总结
The goals of this study are to 1) examine the relationships among inflammation, obesity, and asthma in people with HIV and 2) to test if special subtypes of cells or markers are present in the blood and lungs of people with HIV with asthma compared to those without asthma.
详细描述
The proposed study involves the recruitment of participant population and the use of data from the existing research study cohorts that have been recruited and have provided informed consent for participation. Participants meet all inclusion/exclusion criteria will be enrolled into the study. Participants in the existing research study cohorts have pulmonary function testing, chest CT scans, and blood draws at each study visit which occurs every 18 months for 3 visits. Some of the study procedures may not be repeated if they were done as part of other research projects.
- Main study visit
The following research procedures may be performed over the course of one or more visits to accommodate scheduling needs. The study visit will take place at the Montefiore Clinical and Translational Research Center and the University of Pittsburgh Asthma Institute in the University of Pittsburgh Medical Center - Montefiore Hospital and may take up to 4 hours to complete.
- Informed consent
- Medical history review and demographics
- Review of inclusion/exclusion criteria
- Physical examination to include vital signs, weight and height, waist, hip, and thigh circumferences.
- Urine pregnancy test for female of childbearing potential
- Asthma-focused and quality of life questionnaire
- Exhaled Nitric Oxide (eNO) measurement
- Spirometry
- Methacholine challenge testing - will not need to be repeated if the participant had done this as part of another study in the past 6 months.
- Chest/Abdominal CT scans (If the participant has had the Chest CT scan done within 6 months as part of other research study, they will not be repeated for study purposes. Only the Abdominal CT will be performed)
- Research blood sampling for biomarker analyses - some of this blood will also be used for pre-bronchoscopy testing in the case that the participant qualifies and is interested in undergoing part 2, the bronchoscopy visit.
- Adipose tissue biopsy (Fat Biopsy): performed on participants with a BMI≥25). This will be repeated if done previously because testing to be done on the fat will be different than what had been tested on the fat previously.
- Optional sub-study
On a separate visit, only a subset of 60 selected participants will be asked to undergo the following procedures to obtain additional lung biological samples. This visit is optional for participants who are willing to participate in the bronchoscopy portion. The investigators will try to recruit an equal number (n=15 per group) of obese asthmatics, obese non-asthmatics, non-obese asthmatics, and non-obese non-asthmatics. The visit will take place in the Montefiore Clinical Translational Research Center (MUH-CTRC). The bronchoscopy procedure will take about 30-45 minutes, but the preparation and recovery time will usually make the visit about 4-8 hours total.
Participants will be expected to fast for 8 hours prior to the bronchoscopy procedure and refrain from drinking any liquids the day of the procedure. Participants may take their usual medicines with sips of water.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Subject who have been previously determined to be HIV positive through testing
排除标准
- •Pregnancy or breast-feeding
- •Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.)
- •Heart condition such as tachycardia, angina or arrhythmias
- •Acute respiratory infection: increasing respiratory symptoms or fever (temperature >100.4°F [38°C]) within 4 weeks of study entry
- •Hospitalization within 4 weeks of study entry
- •Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings (participant may return for screening after blood pressure is controlled)
- •Active cancer requiring systemic chemotherapy or radiation
- •Active infection of lungs, brain, or abdomen; or intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator
- •History of prior lung resection
结局指标
主要结局
Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV
时间窗: Baseline
The investigator will test association of adiposity (body mass index, waist circumference, computed tomography (CT)-measured visceral adiposity) with prevalence of asthma and longitudinal progression of airway obstruction. the blood and lungs of people with HIV with asthma compared to those without asthma.
次要结局
- Correlation between leptin and asthma susceptibility in HIV.(Baseline)
- Correlation between adiponectin, asthma susceptibility, and airway remodeling in HIV.(Baseline)
- Adipose tissue-related inflammation contributes to asthma susceptibility and airway remodeling in HIV.(Baseline)
- Low L-arginine increases asthma risk and airway remodeling in HIV.(Baseline)
- Low ADMA increases asthma risk and airway remodeling in HIV.(Baseline)
研究者
Alison Morris
Professor
University of Pittsburgh