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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected ART-naïve | HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-energy X-ray absorptiometry | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body composition measures | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Energy Expenditure (REE) measures | 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 | Assessed using EndoPAT (values reported as a reactive hyperemia index RHI) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Grace McComsey, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Urine, plasma, feces
| Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year |
| calcium score measures | Assessed using CT scans | Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year |
| central obesity | 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 | 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 | 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 | 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |