An observational study in Asthma, HIV and Adiposity, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-13.
Sponsored by University of Pittsburgh · Observational
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.
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.
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.
If Methacholine challenge was done more than 30 days prior to the visit two date, pulmonary function tests will be repeated.
Under local anesthesia, participants will undergo bronchoscopy with BAL for microbiologic specimens. A light intravenous anesthetic will be titrated to provide participant comfort if necessary. Vitals signs will be monitored continuously before, during, and after the procedure. This procedure consists of 3 stages.
Following the bronchoscopy procedure, participants will be closely monitored in the bronchoscopy recovery area or return to the CTRC. Rarely, the participant's asthma may worsen during or after the procedure. Appropriate medical treatments or overnight observation will be provided if needed. Participants will not be allowed to drive home after the bronchoscopy. This is because the sedatives used during the procedure may decrease driving ability. The investigators will ask for the contact name and number of the person that will pick up the participant after the bronchoscopy
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 102 is below the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
HIV positive individuals in the Pittsburgh area
Exclusion Criteria:
Blood will be drawn for plasma, serum, and peripheral blood mononuclear cells.
The following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL).
Spirometry is a simple breathing test that measures the amount of air in one's lungs and how well one can move that air by forcefully blowing 3 or more times into a mouthpiece. A series of these maneuvers will be performed under the instruction of a respiratory technician or respiratory therapist.
Also known as: Lung function testing
A methacholine challenge is a common test often used to support a diagnosis of asthma. The test consists of inhaling increasing doses of methacholine through a nebulizer to assess how quickly the participant's airways narrow.
Also known as: Asthma Test
There will be a standard chest CT and an abdominal CT. The CT scans capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and the abdomen and will be performed during a breath-hold at end-inspiration. The investigators will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized. If the participant has had a research chest CT scan done recently, only the abdomen CT will be done.
Also known as: CT scan of the chest, CT scan of the abdomen
All female participants with childbearing potential will be asked to provide a urine sample for pregnancy testing. The result of the pregnancy test must be negative in order for her to be in this research study.
The doctor will obtain a sample of fat cells from the participant's abdomen. Numbing medicine will be applied. A needle is placed through the skin \& into the fat pad under the skin. A blunt-tip hollow cannula is then used to aspirate fat tissue through the incision.
Also known as: Fat pad biopsy, Fat biopsy
The investigators will measure concentrations of exhaled nitric oxide by asking the participant to inhale deeply, and then exhale very slowly into a mouthpiece for between 10-15 seconds.
Also known as: ENO measurement
Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV
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.
Time frame: Baseline
Correlation between leptin and asthma susceptibility in HIV.
Leptin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.
Time frame: Baseline
Correlation between adiponectin, asthma susceptibility, and airway remodeling in HIV.
Adiponectin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.
Time frame: Baseline
Adipose tissue-related inflammation contributes to asthma susceptibility and airway remodeling in HIV.
Using abdominal adipose tissue biopsies, the investigators will phenotype adipose-specific inflammatory cells and pathways and determine associations with asthma, airway remodeling, and longitudinal progression of airway obstruction.
Time frame: Baseline
Low L-arginine increases asthma risk and airway remodeling in HIV.
The investigator will measure L-arginine in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate L-arginine with CT and biopsy measures of airway remodeling.
Time frame: Baseline
Low ADMA increases asthma risk and airway remodeling in HIV.
The investigator will measure ADMA in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate ADMA with CT and biopsy measures of airway remodeling.
Time frame: Baseline
Plan to share: Undecided
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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