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NCT04451980 · ClinicalTrials.gov registry record

The HIV, Adipose Tissue Immunology, and Metabolism Study

A clinical trial of Diabetes Mellitus, Type 2 and HIV, sponsored by Vanderbilt University Medical Center.

Active
Registry status
172
Enrollment target
1
Study location

NCT04451980: Active study of Diabetes Mellitus, Type 2 and HIV, sponsored by Vanderbilt University Medical Center.

NCT04451980 is a study of Diabetes Mellitus, Type 2 and HIV that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 172 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04451980, a study of Diabetes Mellitus, Type 2 and HIV, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.

ACTIVE NOT RECRUITING
Registry status
172 participants
Enrollment target
1
Study location

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.

Primary Outcome

Flow cytometry measurement of adipose tissue T cell surface marker phenotypes and sequencing of T cell receptors, compared by HIV and diabetes status

Interventions

  • RADIATION CT scan
  • DIAGNOSTIC_TEST Oral glucose tolerance test
  • DIAGNOSTIC_TEST Blood collection
  • PROCEDURE Subcutaneous adipose tissue biopsy

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 172 participants
Start Date 2017-08-31
Est. Completion 2027-01-31

What the registry record for NCT04451980 still lists

NCT04451980 is an observational study that tracks outcomes without assigning an intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which CT scan is the first listed.

NCT04451980 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT04451980 about?

NCT04451980 is a clinical study titled "The HIV, Adipose Tissue Immunology, and Metabolism Study". 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 ...

What is the current status of trial NCT04451980?

This trial is currently active not recruiting. The enrollment target is 172 participants. The study started on 2017-08-31. Estimated completion is 2027-01-31.

What conditions does trial NCT04451980 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, HIV.

What interventions are being tested in trial NCT04451980?

The interventions under investigation include: CT scan (RADIATION), Oral glucose tolerance test (DIAGNOSTIC_TEST), Blood collection (DIAGNOSTIC_TEST), Subcutaneous adipose tissue biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT04451980?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04451980 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus, Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04451980's enrollment target sits among peer trials

172 163rd of 348 higher than 186 of 348 other Diabetes Mellitus, Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04451980, the US trial registry maintained by the National Library of Medicine. NCT04451980 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.