Status:
ACTIVE_NOT_RECRUITING
The HIV, Adipose Tissue Immunology, and Metabolism Study
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Hiv
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief 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 d...
Detailed Description
With the introduction of effective antiretroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic di...
Eligibility Criteria
Inclusion
- HIV+ Participants:
- 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)
Exclusion
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (\>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
- HIV-negative Participants:
- Inclusion Criteria:
- 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)
- Exclusion criteria:
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (\>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
Key Trial Info
Start Date :
August 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04451980
Start Date
August 31 2017
End Date
January 31 2027
Last Update
April 1 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37209