VAMOS: The Visceral Adiposity Measurement and Observation Study

Sponsor

Theratechnologies (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05383456

Collaborator

Dacima Consulting (Other), Norwich Clinical Research Associates Ltd. (Other), Medpace, Inc. (Industry), Vanderbilt University Medical Center (Other), Echosens (Industry)

400

Enrollment

Locations

11.4

Anticipated Duration (Months)

66.7

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Visceral Adiposity Measurement and Observation Study

Condition or Disease	Intervention/Treatment	Phase
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 BMI Ectopic Fat Liver Fat Hepatic Steatosis	Diagnostic Test: Diagnostic Test Drug: HIV Anti-retroviral Background Therapy

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

The Visceral Adiposity Measurement and Observation Study

Actual Study Start Date :

Apr 18, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study Participants 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 Standard diagnostic tests. Other Names: CT Scan Fibroscan Urine and Blood testing Drug: HIV Anti-retroviral Background Therapy All participants are required be on continuous HIV Anti-retroviral Background Therapy. No intervention on drug is part of the Study.

Arm

Intervention/Treatment

Study Participants

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

Standard diagnostic tests.

Other Names:

CT Scan

Fibroscan

Urine and Blood testing

Drug: HIV Anti-retroviral Background Therapy

All participants are required be on continuous HIV Anti-retroviral Background Therapy. No intervention on drug is part of the Study.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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 SF-36 questionnaire [Baseline]
Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
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.
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.
Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute [Baseline]
To evaluate liver disease (hepatic steatosis (HS))
Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa [Baseline]
To evaluate liver disease (hepatic fibrosis (HF))
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruane Clinical Research	Los Angeles	California	United States	90036
2	AIDS Healthcare Foundation	Miami Beach	Florida	United States	33133
3	AIDS Healthcare Foundation	Miami Beach	Florida	United States	33140
4	Bliss Health	Orlando	Florida	United States	32806
5	AIDS Healthcare Foundation	New York	New York	United States	10001
6	Fight Community Health Centers	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Theratechnologies
Dacima Consulting
Norwich Clinical Research Associates Ltd.
Medpace, Inc.
Vanderbilt University Medical Center
Echosens

Investigators

Principal Investigator: Jordan Lake, MD, The University of Texas Health Science Center, Houston
Principal Investigator: John Koethe, MD, Vanderbilt University Medical Center
Principal Investigator: Jeffery Carr, DR, Vanderbilt University Medical Center