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The HIV, Adipose Tissue Immunology, and Metabolism Study

NCT04451980 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 172

Last updated 2026-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Hiv
  • Diabetes Mellitus, Type 2

Interventions

PROCEDURE

Subcutaneous adipose tissue biopsy

Percutaneous adipose tissue biopsy

RADIATION

CT scan

CT scan of chest and abdomen without contrast

DIAGNOSTIC_TEST

Oral glucose tolerance test

Ingestion of 75g of oral glucose syrup and measurement of blood glucose and insulin at time 0, 15 min, 30 min, 60 min, 90 min, and 120 min.

DIAGNOSTIC_TEST

Blood collection

Fasting blood collection for plasma cytokines and T cell phenotypes.

Sponsors & Collaborators

Principal Investigators

  • John Koethe, MD · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2020-03-13
Completion
2026-05-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04451980 on ClinicalTrials.gov