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NCT04439448 · ClinicalTrials.gov registry record
Adipose Tissue and Immune Activation in HIV
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 100
- Enrollment target
NCT04439448 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 100 participants.
The verdict
NCT04439448 has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
The prevalence of HIV-associated wasting declined dramatically with the introduction of effective antiretroviral therapy (ART), but as patients survive longer on treatment the proportion of overweight (body mass index \[BMI\] \>25 kg/m2) and obese (BMI \>30 kg/m2) HIV-infected individuals has been rising over time and is reaching parity with the general population. Adipose tissue has broad effects on immune function relevant to HIV infection, including the basal inflammatory state and peripheral lymphocyte populations, but there are few data on the effects of high adiposity on HIV immunology. This issue is directly relevant to promoting the long-term health of ART-treated individuals, many of which can now survive for decades on treatment, as emerging evidence suggests that increased immune activation is a major risk factor for the development of cardiovascular and metabolic diseases in this population. HIV-infected individuals on ART have an approximately 2-fold higher risk of myocardial infarction and a 4-fold higher risk of type 2 diabetes mellitus, and the proportion of deaths among HIV-infected individuals due to non-AIDS conditions now exceeds those due to AIDS. Despite the increasing proportion of overweight and obese HIV-infected persons, few prior studies have investigated the interaction between adipose tissue, immune activation, and risk factors for cardiovascular and metabolic disease in treated HIV. The overall goal of this study is to understand the complex relationships between adipose tissue, innate and cellular immune activation, and metabolic and cardiovascular disease risk factors in persons on long-term antiretroviral therapy. To this end, we will use an observational, cross-sectional cohort design to compare in vivo markers of immune activation, ex vivo cytokine expression, and metabolic and cardiovascular disease markers in HIV-infected individuals with a range of body composition profiles and between overweight/obese HIV-infected and uninfect
Interventions
- DIAGNOSTIC_TEST Blood collection
- RADIATION dual-energy X-ray absorptiometry (DEXA) scan
- OTHER Carotid and branchial artery ultrasound
- DIAGNOSTIC_TEST 2-hour oral glucose tolerace test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-04-12 |
| Est. Completion | 2020-02-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04439448
The ClinicalTrials.gov registry entry for NCT04439448 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Blood collection is the first listed.
NCT04439448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04439448 about?
NCT04439448 is a clinical study titled "Adipose Tissue and Immune Activation in HIV". The prevalence of HIV-associated wasting declined dramatically with the introduction of effective antiretroviral therapy (ART), but as patients survive longer on treatment the proportion of overweight (body mass index \[BMI\] \>25 kg/m2) and obese (BMI \>30 kg/m2) HIV-infected individuals has been r...
What is the current status of trial NCT04439448?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2013-04-12. Estimated completion is 2020-02-15.
What interventions are being tested in trial NCT04439448?
The interventions under investigation include: Blood collection (DIAGNOSTIC_TEST), dual-energy X-ray absorptiometry (DEXA) scan (RADIATION), Carotid and branchial artery ultrasound (OTHER), 2-hour oral glucose tolerace test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04439448?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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