The Cleveland Cardiometabolic Cohort

January 26, 2026 updated by: Grace McComsey, University Hospitals Cleveland Medical Center

Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: The Cleveland Cardiometabolic Cohort

In this observational study, the investigators will examine the changes in body composition in HIV-infected subjects before and after initiation of HIV treatment, and look at the correlations with changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effects of lifestyle factors on body composition changes after antiretroviral therapy (ART) are unknown, and as such, investigators will use this prospective observational cohort to study relationships between lifestyle factors, including diet, physical activity and illicit drug use, with changes in body composition after ART. In addition, the effect of the body fat changes will be correlated to changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be primarily recruited from the practice of the investigator (the Special Immunology Unit (SIU) at University Hospitals Case Medical Center). All subjects seen at the Special Immunology Unit who meet the inclusion/exclusion criteria will be approached for study participation. Subjects who see physicians outside of the SIU may be eligible as well if they contact the study team and meet the inclusion criteria.

Description

Inclusion Criteria:

  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
  • Provides written informed consent and is capable of reading and comprehending the informed consent
  • Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped >6 months prior to study entry
  • Is planning on starting antiretroviral therapy as part of routine clinic care

Exclusion Criteria:

  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-infected ART-naïve
HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen
Diagnostic test: Dual-energy X-ray absorptiometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition measures
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Assessed using DEXA (dual energy x-ray absorptiometry) scans which will be quantifying total body fat
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Energy Expenditure (REE) measures
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Assessed using a BodyGem REE calculator (values in KCal)
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
endothelial function measures
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Assessed using EndoPAT (values reported as a reactive hyperemia index RHI)
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
calcium score measures
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Assessed using CT scans
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
central obesity
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measured with waist circumference using a tape measure (in cm)
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Lipids measures
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
used measuring blood levels of triglycerides (mg/dL); serum high-density lipoprotein (mg/dL) ; cholesterol (mg/dL); low density lipoprotein (mg/dL)
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Fasting plasma glucose measures
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
fasting plasma glucose test is performed after a person has fasted for at least 8 hours (measured in mg/dL)
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Metabolic syndrome
Time Frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Metabolic syndrome will be defined using the following measures: central obesity, serum triglycerides , serum high-density lipoprotein (HDL); cholesterol levels and fasting plasma glucose
Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Grace McComsey, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

May 19, 2025

Study Completion (Actual)

May 19, 2025

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-16-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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