Skip to main content
OpenTrials
Completed

NCT Number: NCT03059121

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-energy X-ray absorptiometry

Diagnostic Test

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. calcium score measures

    Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

    Assessed using CT scans

  4. 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)

  5. 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)

  6. 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)

  7. 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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2017
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.