The Cleveland Cardiometabolic Cohort
- Conditions
- LipodystrophyHIV
- Interventions
- Diagnostic Test: Dual-energy X-ray absorptiometry
- Registration Number
- NCT03059121
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- Pregnancy or lactation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV-infected ART-naïve Dual-energy X-ray absorptiometry HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen
- Primary Outcome Measures
Name Time Method Body composition measures 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 Outcome Measures
Name Time Method endothelial function measures Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year Assessed using EndoPAT (values reported as a reactive hyperemia index RHI)
calcium score measures Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year Assessed using CT scans
Metabolic syndrome 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
Resting Energy Expenditure (REE) measures Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year Assessed using a BodyGem REE calculator (values in KCal)
central obesity Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year measured with waist circumference using a tape measure (in cm)
Lipids measures 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)
Fasting plasma glucose measures 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)
Trial Locations
- Locations (1)
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States