The Visceral Adiposity Measurement and Observation Study (VAMOS)

November 14, 2023 updated by: Theratechnologies
The Visceral Adiposity Measurement and Observation Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Aids Healthcare Foundation
      • Miami Beach, Florida, United States, 33133
        • Aids Healthcare Foundation
      • Miami Beach, Florida, United States, 33140
        • Aids Healthcare Foundation
      • Orlando, Florida, United States, 32806
        • Bliss Health
    • New York
      • New York, New York, United States, 10001
        • Aids Healthcare Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Fight Community Health Centers
    • Texas
      • Dallas, Texas, United States, 75208
        • Prism Health North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The overall study population will include all participants who provide informed consent, are enrolled in the study, and complete all study procedures as required.

The cardiovascular risk analysis population will not include participants who have history of CVD (myocardial infarction, cerebrovascular accident, heart failure, or atrial fibrillation).

Diagnosis of normal versus excess VA using published criteria12,15,16,20 (normal visceral adiposity (NVA) versus EVA) will be based on CT evidence of VA cross-sectional area (<130cm2 or ≥130cm2, respectively).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical waist circumference measurement (in cm).
Time Frame: 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.
Baseline
Iliac waist circumference measurement (in cm).
Time Frame: 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.
Baseline
Visceral Adiposity Measurement by CT surface area (cm2).
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visceral Adiposity Measurement by CT surface area (cm2)
Time Frame: 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.
Baseline
Visceral Adiposity Measurement by CT volume (cm3).
Time Frame: 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.
Baseline
Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.
Time Frame: 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).
Baseline
Health related quality of life evaluation by SF-36 questionnaire
Time Frame: Baseline
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
Time Frame: Baseline
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)
Time Frame: 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.
Baseline
Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute
Time Frame: Baseline
To evaluate liver disease (hepatic steatosis (HS))
Baseline
Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa
Time Frame: Baseline
To evaluate liver disease (hepatic fibrosis (HF))
Baseline
Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).
Time Frame: 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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theratechnologies

Collaborators

Vanderbilt University Medical Center
Medpace, Inc.
Dacima Consulting
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH9507-CTR-1030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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