The Visceral Adiposity Measurement and Observation Study

Completed

• Conditions: HIV Lipodystrophy; BMI; HIV-Infections; NASH; Liver Fibrosis; Waist Circumference; Ectopic Fat; Liver Fat; Lipohypertrophy; Hepatic Fibrosis
• Interventions: Diagnostic Test: Diagnostic Test; Drug: HIV Anti-retroviral Background Therapy

• Registration Number: NCT05383456
• Lead Sponsor: Theratechnologies

Brief Summary

The Visceral Adiposity Measurement and Observation Study

Detailed Description

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 Timeline

• Study First Submitted: 2022-04-08
• Study Start: 2022-04-18
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

1. Adult, ≥18 years
2. HIV+, on continuous ART for ≥12 months
3. ≥3 years since initiation of ART
4. 20.0 ≤ BMI ≤ 40.0 kg/m2

Exclusion Criteria

1. Detectable HIV plasma viremia 12 months prior enrollment, defined by ≥1 measurement of HIV-1 ribonucleic acid (RNA) > 1000/mL
2. Unable or unwilling to undergo any study procedures
3. Known hepatic cirrhosis
4. Active hepatitis C within past 12 months, defined by detectable hepatitis C RNA
5. Hepatitis B positive
6. Current pregnancy or breastfeeding
7. History of liver transplant
8. Self-reported weekly alcohol consumption meets National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for problematic drinking (binge or chronic daily intake)
9. Any active malignancy, excluding non-melanoma skin cancer
10. Patient has been treated with tesamorelin or human growth hormone within the last 12 months
11. Patient has used insulin in the previous year
12. Patient has undergone bariatric surgery in the year prior to enrollment or is currently undergoing a weight loss program

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Participants	Diagnostic Test	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.
Study Participants	HIV Anti-retroviral Background Therapy	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.

Primary Outcome Measures

Name	Time	Method
Visceral Adiposity Measurement by CT surface area (cm2).	Baseline	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.
Umbilical waist circumference measurement (in cm).	Baseline	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.
Iliac waist circumference measurement (in cm).	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Visceral Adiposity Measurement by CT surface area (cm2)	Baseline	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.
Visceral Adiposity Measurement by CT volume (cm3).	Baseline	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.
Health related quality of life evaluation by SF-36 questionnaire	Baseline	Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute	Baseline	To evaluate liver disease (hepatic steatosis (HS))
Framingham Cardiovascular Risk strata (low, intermediate or high)	Baseline	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.
Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).	Baseline	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).
Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.	Baseline	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).
Health related quality of life evaluation by VAMOS disease specific questionnaire	Baseline	Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa	Baseline	To evaluate liver disease (hepatic fibrosis (HF))

Trial Locations

Locations (5)

Ruane Clinical Research; 🇺🇸 Los Angeles, California, United States

Prism Health North Texas; 🇺🇸 Dallas, Texas, United States

Fight Community Health Centers; 🇺🇸 Philadelphia, Pennsylvania, United States

Bliss Health; 🇺🇸 Orlando, Florida, United States

AIDS Healthcare Foundation; 🇺🇸 New York, New York, United States