The Cleveland Cardiometabolic Cohort

NCT ID: NCT03059121

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Lipodystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV-infected ART-naïve

HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen

Dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

Interventions

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Dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Grace McComsey

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grace McComsey, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Danielle Labbato, BSN

Role: CONTACT

216-844-2739

Grace McComsey, MD

Role: CONTACT

Facility Contacts

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Danielle Labbato, BSN

Role: primary

216-844-2739

Other Identifiers

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06-16-19

Identifier Type: -

Identifier Source: org_study_id

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