The Visceral Adiposity Measurement and Observation Study

Study Overview
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Brief Summary
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The Visceral Adiposity Measurement and Observation Study

Detailed Description
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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.

Official Title
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The Visceral Adiposity Measurement and Observation Study

Conditions
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BMI, HIV, HIV-Infections, HIV-1-infection, HIV I Infection, HIV Lipodystrophy, HIV Infection Primary, HIV-Associated Lipodystrophy, HIV Disease Progression, Lipohypertrophy, Liver Diseases, NAFLD, NASH, Liver Fibrosis, Hepatic Fibrosis, Waist Circumference, Ectopic Fat, Liver Fat, Hepatic Steatosis

Intervention / Treatment
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* Diagnostic Test: Diagnostic Test
* Drug: HIV Anti-retroviral Background Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, ≥18 years HIV+, on continuous ART for ≥12 months ≥3 years since initiation of ART 20.0 ≤ BMI ≤ 40.0 kg/m2 Exclusion Criteria: Detectable HIV plasma viremia 12 months prior enrollment, defined by ≥1 measurement of HIV-1 ribonucleic acid (RNA) > 1000/mL Unable or unwilling to undergo any study procedures Known hepatic cirrhosis Active hepatitis C within past 12 months, defined by detectable hepatitis C RNA Hepatitis B positive Current pregnancy or breastfeeding History of liver transplant Self-reported weekly alcohol consumption meets National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for problematic drinking (binge or chronic daily intake) Any active malignancy, excluding non-melanoma skin cancer Patient has been treated with tesamorelin or human growth hormone within the last 12 months Patient has used insulin in the previous year Patient has undergone bariatric surgery in the year prior to enrollment or is currently undergoing a weight loss program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Participants<br>Waist and hip circumferences, CT Scan and FibroScan and Quality of Life questionnaire, vital signs, urine and blood testing in Adults with HIV on continuous Anti-Retroviral Therapy treatment. | Diagnostic Test: Diagnostic Test<br>* Standard diagnostic tests.<br>* Other names: Urine and Blood testing;Drug: HIV Anti-retroviral Background Therapy<br>* All participants are required be on continuous HIV Anti-retroviral Background Therapy. No intervention on drug is part of the Study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 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. | 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. | Baseline | 
| Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute | To evaluate liver disease (hepatic steatosis (HS)) | Baseline | 
| Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa | To evaluate liver disease (hepatic fibrosis (HF)) | 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). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Infections, HIV-1-infection, HIV Lipodystrophy, HIV Infection Primary, HIV-Associated Lipodystrophy, HIV Disease Progression, Lipohypertrophy, Liver Disease, NAFLD, Liver Fat, Hepatic Steatosis, NASH, Liver Fibrosis and Hepatic Fibrosis, Ectopic Fat, Pericardial Fat, Muscle Fat/Density, Liver CAP, Liver VTCE, Waist Circumference, Anthropometric Measurements, BMI, Hip Circumference, Waist to Hip Ratio