The HIV, Adipose Tissue Immunology, and Metabolism Study
Completed
Conditions studied: Hiv, Diabetes Mellitus, Type 2
In brief
With the introduction of effective anti-retroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic disease and diabetes in HIV-infected persons compared to the general population. Recent studies from HIV-negative subjects have identified several associations between circulating immune cell populations and impaired glucose tolerance, including increased activated CD4+ and CD8+ T cells, and reduced regulatory T cells. Of note, these same changes in peripheral T cell subsets are frequently observed in patients with chronic HIV infection. The goal of this study is to assess whether the circulating T cell distribution is reflective of the adipose tissue T cell distribution, and to understand whether chronic adipose tissue T cell activation may impair adipocyte (i.e., fat cell) function and insulin sensitivity. If the investigators' hypotheses are correct, this will demonstrate that chronic peripheral immune activation (i.e., high memory T cells, low naïve cells, and increased expression of activation surface markers) is associated with greater adipose-resident CD4+ and CD8+ T cell expression of activation markers, adipose tissue inflammation, and insulin resistance.
Key facts
- Study ID
- NCT04451980
- Run by
- Vanderbilt University Medical Center
- People needed
- 172
- Starts
- 2017-08-31
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- On antiretroviral therapy for at least 18 months
- HIV-1 RNA <400 copies/ml for the prior 12 months
- CD4+ count >350 cells/µl in the prior 12 months
- HbA1c in prior 6 months within specified limits (See Figure)
- Pre-menopausal by self-report or post-menopausal but not on hormone replacement therapy (HRT)
You may not qualify if…
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
- HIV-negative Participants:
- Inclusion Criteria:
- A HbA1c >6.5% or a fasting glucose >126mg/dl, or on anti-diabetic medications for at least 6 months
- Pre-menopausal by self-report or post-menopausal but not on hormone replacement therapy (HRT)
- Exclusion criteria:
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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