Adiposity and Airway Inflammation in HIV-Associated Airway Disease

NCT02975258 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2017-10-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Blood draw

Blood will be drawn for plasma, serum, and peripheral blood mononuclear cells.

OTHER

Questionnaires

The following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL).

PROCEDURE

Spirometry

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.

PROCEDURE

Methacholine challenge test

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.

RADIATION

Quantitative CT scans

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.

PROCEDURE

Urine pregnancy test

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.

PROCEDURE

Adipose biopsy

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.

PROCEDURE

Exhaled nitric oxide measurement

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Alison Morris, MD, MS · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02975258 on ClinicalTrials.gov