The Visceral Adiposity Measurement and Observation Study

NCT05383456 | Completed

• 1 other identifier: TH9507-CTR-1030
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 8

Brief Summary

The Visceral Adiposity Measurement and Observation Study

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Visceral Adiposity Measurement by CT surface area (cm2)

  Baseline

• Visceral Adiposity Measurement by CT volume (cm3).

  Baseline

• Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.

  Baseline

• Health related quality of life evaluation by SF-36 questionnaire

  Baseline

• Health related quality of life evaluation by VAMOS disease specific questionnaire

  Baseline

Study Arms (1)

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; Drug: HIV Anti-retroviral Background Therapy

Interventions

Diagnostic Test DIAGNOSTIC_TEST

Standard diagnostic tests.

Also known as: CT Scan, Fibroscan, Urine and Blood testing

Study Participants

HIV Anti-retroviral Background Therapy DRUG

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

Study Participants

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Sex will be defined by sex assigned at birth. Gender will be by self-declared gender identity. Thus: * Men will include cis-identified males and trans men. * Women will include cis-identified women and trans women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Adult, ≥18 years
• HIV+, on continuous ART for ≥12 months
• ≥3 years since initiation of ART
• ≤ BMI ≤ 40.0 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Theratechnologies: lead
• Dacima Consulting: collaborator
• Medpace, Inc.: collaborator
• Vanderbilt University Medical Center: collaborator
• Echosens: collaborator

Study Sites (8)

Ruane Clinical Research

Los Angeles, California, 90036, United States

Location

AIDS Healthcare Foundation

Fort Lauderdale, Florida, 33308, United States

Location

AIDS Healthcare Foundation

Miami Beach, Florida, 33133, United States

Location

AIDS Healthcare Foundation

Miami Beach, Florida, 33140, United States

Location

Bliss Health

Orlando, Florida, 32806, United States

Location

AIDS Healthcare Foundation

New York, New York, 10001, United States

Location

Fight Community Health Centers

Philadelphia, Pennsylvania, 19107, United States

Location

Prism Health North Texas

Dallas, Texas, 75208, United States

Location

Related Publications (24)

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• Lemoine M, Assoumou L, De Wit S, Girard PM, Valantin MA, Katlama C, Necsoi C, Campa P, Huefner AD, Schulze Zur Wiesch J, Rougier H, Bastard JP, Stocker H, Mauss S, Serfaty L, Ratziu V, Menu Y, Schlue J, Behrens G, Bedossa P, Capeau J, Ingiliz P, Costagliola D; ANRS-ECHAM Group. Diagnostic Accuracy of Noninvasive Markers of Steatosis, NASH, and Liver Fibrosis in HIV-Monoinfected Individuals at Risk of Nonalcoholic Fatty Liver Disease (NAFLD): Results From the ECHAM Study. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):e86-e94. doi: 10.1097/QAI.0000000000001936.

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• Gabriel CL, Ye F, Fan R, Nair S, Terry JG, Carr JJ, Silver H, Baker P, Hannah L, Wanjalla C, Mashayekhi M, Bailin S, Lima M, Woodward B, Izzy M, Ferguson JF, Koethe JR. Hepatic Steatosis and Ectopic Fat Are Associated With Differences in Subcutaneous Adipose Tissue Gene Expression in People With HIV. Hepatol Commun. 2021 Feb 27;5(7):1224-1237. doi: 10.1002/hep4.1695. eCollection 2021 Jul.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample for lipid analysis.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV-Associated Lipodystrophy Syndrome; Liver Diseases; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fatty Liver; HIV Infections

Interventions

Diagnostic Tests, Routine; Tomography, X-Ray Computed; Urination; Hematologic Tests

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: May 20, 2022
• Study Start: April 18, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)