The Visceral Adiposity Measurement and Observation Study

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Brief Title

The Visceral Adiposity Measurement and Observation Study

Official Title

The Visceral Adiposity Measurement and Observation Study

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 Type

Observational

Primary Outcome

Umbilical waist circumference measurement (in cm).

Secondary Outcome

 Visceral Adiposity Measurement by CT surface area (cm2)

Condition

HIV

Intervention

Diagnostic Test

Study Arms / Comparison Groups

 Study Participants
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

400

Start Date

April 18, 2022

Completion Date

April 2023

Primary Completion Date

April 2023

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jordan Lake, MD, 438-994-7240, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT05383456

Organization ID

TH9507-CTR-1030

Responsible Party

Sponsor

Study Sponsor

Theratechnologies

Collaborators

 Dacima Consulting

Study Sponsor

Jordan Lake, MD, Principal Investigator, The University of Texas Health Science Center, Houston

Verification Date

February 2023