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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 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.

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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.

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 Tells You About NCT04451980

The ClinicalTrials.gov registry entry for NCT04451980 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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