NCT04451980Completed
The HIV, Adipose Tissue Immunology, and Metabolism Study
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 172 (actual)
- First submitted
- 16 Jun 2020
- Start date
- Aug 2017
- Primary completion date
- Mar 2020
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- HIV, Type 2 diabetes
- NCT number
- NCT04451980
What you commit to
- Study type: Observational
- Participants enrolled: 172
- From Aug 2017 to the primary completion date, Mar 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of DPP-4 inhibitors.
Other illness
- Known inflammatory or rheumatologic conditions
- Current use of DPP-4 inhibitors.
- HIV-negative Participants:
- Known inflammatory or rheumatologic conditions
Other
- Heavy alcohol (\>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Heavy alcohol (\>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
Who the study is looking for
- 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)
- 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)
Criteria the registry did not label
- HIV+ Participants:
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.