The Visceral Adiposity Measurement and Observation Study
Visceral adiposity (VA) is a form of ectopic fat deposition that correlates with cardiometabolic risk in both the general population and among people with human immunodeficiency virus (HIV) (PWH).1 Excess VA (EVA) is prevalent among PWH,2,3 and prevalence rises with age and time on antiretroviral treatment.3 Effective plasma virologic suppression is not protective against EVA and associated comorbidities, possibly due to adverse metabolic effects of certain antiretroviral agents, the low-level expression of HIV gene products within the adipose tissue, and other factos.4 Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy (ART),2,3 it may go unrecognized or be mischaracterized as generalized obesity. Whereas obesity and EVA both increase waist circumference (WC), they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots, whereas individuals with EVA accumulate fat within the abdominal cavity. Ectopic fat accumulation (EFA) also occurs at various other depots, namely around and within various internal organs (e.g., the heart, skeletal muscle, liver, and pancreas).1,5 For purposes of the VAMOS study, EFA is defined as the amount of pericardial fat, skeletal muscle fat, and liver fat the VAMOS study subjects have. VA for the VAMOS study is held separately as it is the primary endpoint. Because it represents a potentially modifiable cardiovascular risk factor among PWH, simple, practical surrogate markers are needed to identify patients with probable EVA. Anthropometric measurements such as WC correlate with EVA in the general population1, but their predictive value is less well defined for subgroups of PWH.
Study Type
OBSERVATIONAL
Enrollment
196
Standard diagnostic tests.
All participants are required be on continuous HIV Anti-retroviral Background Therapy. No intervention on drug is part of the Study.
Ruane Clinical Research
Los Angeles, California, United States
AIDS Healthcare Foundation
Fort Lauderdale, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
Bliss Health
Orlando, Florida, United States
AIDS Healthcare Foundation
New York, New York, United States
Fight Community Health Centers
Philadelphia, Pennsylvania, United States
Prism Health North Texas
Dallas, Texas, United States
Umbilical waist circumference measurement (in cm).
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Time frame: Baseline
Iliac waist circumference measurement (in cm).
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Time frame: Baseline
Visceral Adiposity Measurement by CT surface area (cm2).
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Time frame: Baseline
Visceral Adiposity Measurement by CT surface area (cm2)
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) and BMI (Outcome 6) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Time frame: Baseline
Visceral Adiposity Measurement by CT volume (cm3).
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) will be assessed for a relationship to Visceral Adiposity as measured by CT volume.
Time frame: Baseline
Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) and BMI will be assessed for a predicting relationship to Visceral Adiposity as measured by CT surface area (Outcome 4), Visceral Adiposity as measured by CT volume (Outcome 5), Framingham Cardiovascular Risk strata (Outcome 9), Liver disease (Outcome 10 and 11) or Glucose homeostasis (Outcome 12).
Time frame: Baseline
Health related quality of life evaluation by SF-36 questionnaire
Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
Time frame: Baseline
Health related quality of life evaluation by VAMOS disease specific questionnaire
Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
Time frame: Baseline
Framingham Cardiovascular Risk strata (low, intermediate or high)
Participant age in year, HDL-cholesterol in mmol/L, Total Cholesterol in mmol/L and systolic blood pressure in mmHg will be combined to determine the Framingham Cardiovascular Risk strata (low, intermediate or high). Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) will be assessed for a relationship to Framingham Cardiovascular Risk strata.
Time frame: Baseline
Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute
To evaluate liver disease (hepatic steatosis (HS))
Time frame: Baseline
Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa
To evaluate liver disease (hepatic fibrosis (HF))
Time frame: Baseline
Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) and BMI (Outcome 6) will be assessed for a predicting relationship to Visceral Adiposity as measured by CT surface area (Outcome 4), Visceral Adiposity as measured by CT volume (Outcome 5), Framingham Cardiovascular Risk strata (Outcome 9), Liver disease (Outcome 10 and 11) or Glucose homeostasis (Outcome 12).
Time frame: Baseline
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