The Visceral Adiposity Measurement and Observation Study

HIV Clinical Trial

— VAMOS  

Official title:

The Visceral Adiposity Measurement and Observation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383456
• Other study ID #: TH9507-CTR-1030
• Status: Completed
• Start date: April 18, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Theratechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Visceral Adiposity Measurement and Observation Study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• BMI
• Communicable Diseases
• Disease Progression
• Ectopic Fat
• Fatty Liver
• Fibrosis
• Hepatic Fibrosis
• Hepatic Steatosis
• HIV
• HIV Disease Progression
• HIV I Infection
• HIV Infection Primary
• HIV Infections
• HIV Lipodystrophy
• HIV-1-infection
• HIV-Associated Lipodystrophy
• HIV-Associated Lipodystrophy Syndrome
• HIV-Infections
• Infections
• Lipodystrophy
• Lipohypertrophy
• Liver Cirrhosis
• Liver Diseases
• Liver Fat
• Liver Fibrosis
• NAFLD
• NASH

Intervention

Diagnostic Test:
• Diagnostic Test
Standard diagnostic tests.

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.

Locations

Country	Name	City	State
United States	Prism Health North Texas	Dallas	Texas
United States	AIDS Healthcare Foundation	Fort Lauderdale	Florida
United States	Ruane Clinical Research	Los Angeles	California
United States	AIDS Healthcare Foundation	Miami Beach	Florida
United States	AIDS Healthcare Foundation	Miami Beach	Florida
United States	AIDS Healthcare Foundation	New York	New York
United States	Bliss Health	Orlando	Florida
United States	Fight Community Health Centers	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Theratechnologies	Dacima Consulting, Echosens, Medpace, Inc., Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (24)

Alikhani A, Morin H, Matte S, Alikhani P, Tremblay C, Durand M. Association between lipodystrophy and length of exposure to ARTs in adult HIV-1 infected patients in Montreal. BMC Infect Dis. 2019 Sep 18;19(1):820. doi: 10.1186/s12879-019-4446-9. — View Citation

Beraldo RA, Meliscki GC, Silva BR, Navarro AM, Bollela VR, Schmidt A, Foss-Freitas MC. Anthropometric measures of central adiposity are highly concordant with predictors of cardiovascular disease risk in HIV patients. Am J Clin Nutr. 2018 Jun 1;107(6):883-893. doi: 10.1093/ajcn/nqy049. — View Citation

Beraldo RA, Meliscki GC, Silva BR, Navarro AM, Bollela VR, Schmidt A, Foss-Freitas MC. Comparing the Ability of Anthropometric Indicators in Identifying Metabolic Syndrome in HIV Patients. PLoS One. 2016 Feb 26;11(2):e0149905. doi: 10.1371/journal.pone.0149905. eCollection 2016. — View Citation

Falutz J, Rosenthall L, Kotler D, Zona S, Guaraldi G. Surrogate markers of visceral adipose tissue in treated HIV-infected patients: accuracy of waist circumference determination. HIV Med. 2014 Feb;15(2):98-107. doi: 10.1111/hiv.12085. Epub 2013 Sep 22. — View Citation

Fourman LT, Kileel EM, Hubbard J, Holmes T, Anderson EJ, Looby SE, Fitch KV, Feldpausch MN, Torriani M, Lo J, Stanley TL, Grinspoon SK. Comparison of visceral fat measurement by dual-energy X-ray absorptiometry to computed tomography in HIV and non-HIV. Nutr Diabetes. 2019 Feb 25;9(1):6. doi: 10.1038/s41387-019-0073-1. — View Citation

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. — View Citation

Guilbaud L, Guedes JC, Gomez B, Gagne C, Thomas R, Szabo J. Lipohypertrophy, a preliminary estimate in the prevalence in an urban Canadian HIV clinic. Presented at the May 2019 CAHR Conference, Saskatoon SK. Poster 4420.

Hunter GR, Snyder SW, Kekes-Szabo T, Nicholson C, Berland L. Intra-abdominal adipose tissue values associated with risk of possessing elevated blood lipids and blood pressure. Obes Res. 1994 Nov;2(6):563-8. doi: 10.1002/j.1550-8528.1994.tb00106.x. — View Citation

Katzmarzyk PT, Greenway FL, Heymsfield SB, Bouchard C. Clinical utility and reproducibility of visceral adipose tissue measurements derived from dual-energy X-ray absorptiometry in White and African American adults. Obesity (Silver Spring). 2013 Nov;21(11):2221-4. doi: 10.1002/oby.20519. Epub 2013 Aug 13. — View Citation

Katzmarzyk PT, Heymsfield SB, Bouchard C. Clinical utility of visceral adipose tissue for the identification of cardiometabolic risk in white and African American adults. Am J Clin Nutr. 2013 Mar;97(3):480-6. doi: 10.3945/ajcn.112.047787. Epub 2013 Jan 30. — View Citation

Koethe JR, Lagathu C, Lake JE, Domingo P, Calmy A, Falutz J, Brown TT, Capeau J. HIV and antiretroviral therapy-related fat alterations. Nat Rev Dis Primers. 2020 Jun 18;6(1):48. doi: 10.1038/s41572-020-0181-1. Erratum In: Nat Rev Dis Primers. 2020 Jul 2;6(1):54. — View Citation

Koethe JR. Adipose Tissue in HIV Infection. Compr Physiol. 2017 Sep 12;7(4):1339-1357. doi: 10.1002/cphy.c160028. — View Citation

Lake JE, Stanley TL, Apovian CM, Bhasin S, Brown TT, Capeau J, Currier JS, Dube MP, Falutz J, Grinspoon SK, Guaraldi G, Martinez E, McComsey GA, Sattler FR, Erlandson KM. Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection. Clin Infect Dis. 2017 May 15;64(10):1422-1429. doi: 10.1093/cid/cix178. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433. — View Citation

Lemieux S, Prud'homme D, Bouchard C, Tremblay A, Despres JP. A single threshold value of waist girth identifies normal-weight and overweight subjects with excess visceral adipose tissue. Am J Clin Nutr. 1996 Nov;64(5):685-93. doi: 10.1093/ajcn/64.5.685. — View Citation

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. — View Citation

Monczor AN, Li X, Palella FJ Jr, Erlandson KM, Wiley D, Kingsley LA, Post WS, Jacobson LP, Brown TT, Lake JE. Systemic Inflammation Characterizes Lack of Metabolic Health in Nonobese HIV-Infected Men. Mediators Inflamm. 2018 Sep 25;2018:5327361. doi: 10.1155/2018/5327361. eCollection 2018. — View Citation

Neeland IJ, Ross R, Despres JP, Matsuzawa Y, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin B, Zambon A, Barter P, Fruchart JC, Eckel RH; International Atherosclerosis Society; International Chair on Cardiometabolic Risk Working Group on Visceral Obesity. Visceral and ectopic fat, atherosclerosis, and cardiometabolic disease: a position statement. Lancet Diabetes Endocrinol. 2019 Sep;7(9):715-725. doi: 10.1016/S2213-8587(19)30084-1. Epub 2019 Jul 10. — View Citation

O'Neill T, Guaraldi G, Orlando G, Carli F, Garlassi E, Zona S, Despres JP, Ross R. Combined use of waist and hip circumference to identify abdominally obese HIV-infected patients at increased health risk. PLoS One. 2013 May 20;8(5):e62538. doi: 10.1371/journal.pone.0062538. Print 2013. — View Citation

Orlando G, Guaraldi G, Zona S, Carli F, Bagni P, Menozzi M, Cocchi S, Scaglioni R, Ligabue G, Raggi P. Ectopic fat is linked to prior cardiovascular events in men with HIV. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):494-7. doi: 10.1097/QAI.0b013e31824c8397. Erratum In: J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):e120. Gabriella, Orlando [corrected to Orlando, Gabriella]; Giovanni, Guaraldi [corrected to Guaraldi, Giovanni]; Stefano, Zona [corrected to Zona, Stefano]; Federica, Carli [corrected to Carli, Federica]; Pietro, Bagni [corrected to Bagni, Pietro]; Marianna, Me. — View Citation

Pouliot MC, Despres JP, Lemieux S, Moorjani S, Bouchard C, Tremblay A, Nadeau A, Lupien PJ. Waist circumference and abdominal sagittal diameter: best simple anthropometric indexes of abdominal visceral adipose tissue accumulation and related cardiovascular risk in men and women. Am J Cardiol. 1994 Mar 1;73(7):460-8. doi: 10.1016/0002-9149(94)90676-9. — View Citation

Rankinen T, Kim SY, Perusse L, Despres JP, Bouchard C. The prediction of abdominal visceral fat level from body composition and anthropometry: ROC analysis. Int J Obes Relat Metab Disord. 1999 Aug;23(8):801-9. doi: 10.1038/sj.ijo.0800929. — View Citation

Williams MJ, Hunter GR, Kekes-Szabo T, Trueth MS, Snyder S, Berland L, Blaudeau T. Intra-abdominal adipose tissue cut-points related to elevated cardiovascular risk in women. Int J Obes Relat Metab Disord. 1996 Jul;20(7):613-7. — View Citation

Yoo S, Sung MW, Kim H. CT-defined visceral adipose tissue thresholds for identifying metabolic complications: a cross-sectional study in the United Arab Emirates. BMJ Open. 2020 Aug 11;10(8):e031181. doi: 10.1136/bmjopen-2019-031181. — View Citation

Zhou Q, Usadel S, Kern W, Zirlik A, Mueller MC. Real world cardiovascular risk assessment using reduced DAD, SCORE and Framingham equations in a German HIV cohort. Eur Heart J. 2020;41 (Suppl. 2):ehaa946.2914.

* Note: There are 24 references in all — Click here to view all references

Outcome

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