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NCT04451980: HATIM

The HIV, Adipose Tissue Immunology, and Metabolism Study

Active, enrolled Last updated 1 April 2025
What this trial tests

trial testing Subcutaneous adipose tissue biopsy in Hiv in 172 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
31 August 2017
Primary endpoint
13 March 2020
31 January 2027

Quick facts

Lead sponsorVanderbilt University Medical Center
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment172
Start date31 August 2017
Primary completion13 March 2020
Estimated completion31 January 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Hiv or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Single-cell analysis shows that adipose tissue of persons with both HIV and diabetes is enriched for clonal, cytotoxic, and CMV-specific CD4+ T cells.
    Wanjalla CN, McDonnell WJ, Ram R, Chopra A, et al · · 2021 · cited 34× · PMID 33665640 · DOI 10.1016/j.xcrm.2021.100205
  2. Association of alpha-aminoadipic acid with cardiometabolic risk factors in healthy and high-risk individuals.
    Desine S, Gabriel CL, Smith HM, Antonetti OR, et al · · 2023 · cited 15× · PMID 37745703 · DOI 10.3389/fendo.2023.1122391
  3. Changes in subcutaneous white adipose tissue cellular composition and molecular programs underlie glucose intolerance in persons with HIV.
    Bailin SS, Kropski JA, Gangula RD, Hannah L, et al · · 2023 · cited 12× · PMID 37711619 · DOI 10.3389/fimmu.2023.1152003
  4. Hepatic Steatosis and Ectopic Fat Are Associated With Differences in Subcutaneous Adipose Tissue Gene Expression in People With HIV.
    Gabriel CL, Ye F, Fan R, Nair S, et al · · 2021 · cited 12× · PMID 34278171 · DOI 10.1002/hep4.1695
  5. CD4<sup>+</sup> T cells expressing CX3CR1, GPR56, with variable CD57 are associated with cardiometabolic diseases in persons with HIV.
    Wanjalla CN, Gabriel CL, Fuseini H, Bailin SS, et al · · 2023 · cited 11× · PMID 36865544 · DOI 10.3389/fimmu.2023.1099356
  6. Single-Cell Analysis of Subcutaneous Fat Reveals Profibrotic Cells That Correlate With Visceral Adiposity in HIV.
    Bailin SS, Gabriel CL, Gangula RD, Hannah L, et al · · 2024 · cited 10× · PMID 38820087 · DOI 10.1210/clinem/dgae369
  7. The subcutaneous adipose transcriptome identifies a molecular signature of insulin resistance shared with visceral adipose.
    Mashayekhi M, Sheng Q, Bailin SS, Massier L, et al · · 2024 · cited 9× · PMID 38967296 · DOI 10.1002/oby.24064
  8. Mean Coronary Cross-Sectional Area as a Measure of Arterial Remodeling Using Noncontrast CT Imaging in Persons With HIV.
    Werede AT, Terry JG, Nair S, Temu TM, et al · · 2022 · cited 7× · PMID 36382956 · DOI 10.1161/jaha.122.025768

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