Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05383456
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Visceral Adiposity Measurement and Observation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D014554', 'term': 'Urination'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum sample for lipid analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Umbilical waist circumference measurement (in cm).', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Iliac waist circumference measurement (in cm).', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Visceral Adiposity Measurement by CT surface area (cm2).', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Visceral Adiposity Measurement by CT surface area (cm2)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Visceral Adiposity Measurement by CT volume (cm3).', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Health related quality of life evaluation by SF-36 questionnaire', 'timeFrame': 'Baseline', 'description': 'Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.'}, {'measure': 'Health related quality of life evaluation by VAMOS disease specific questionnaire', 'timeFrame': 'Baseline', 'description': 'Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.'}, {'measure': 'Framingham Cardiovascular Risk strata (low, intermediate or high)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute', 'timeFrame': 'Baseline', 'description': 'To evaluate liver disease (hepatic steatosis (HS))'}, {'measure': 'Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa', 'timeFrame': 'Baseline', 'description': 'To evaluate liver disease (hepatic fibrosis (HF))'}, {'measure': 'Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).', 'timeFrame': 'Baseline', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], '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']}, 'referencesModule': {'references': [{'pmid': '31301983', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '31533648', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28915327', 'type': 'BACKGROUND', 'citation': 'Koethe JR. Adipose Tissue in HIV Infection. Compr Physiol. 2017 Sep 12;7(4):1339-1357. doi: 10.1002/cphy.c160028.'}, {'pmid': '22410868', 'type': 'BACKGROUND', '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.'}, {'pmid': '30804324', 'type': 'BACKGROUND', '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.'}, {'pmid': '30570529', 'type': 'BACKGROUND', '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.'}, {'pmid': '28329372', 'type': 'BACKGROUND', '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.'}, {'pmid': '34278171', 'type': 'BACKGROUND', '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.'}, {'pmid': '30356397', 'type': 'BACKGROUND', '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.'}, {'pmid': '26919174', 'type': 'BACKGROUND', '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.'}, {'pmid': '32555389', 'type': 'BACKGROUND', '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.'}, {'pmid': '8141087', 'type': 'BACKGROUND', '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.'}, {'pmid': '23700409', 'type': 'BACKGROUND', '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."}, {'pmid': '16355516', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32788183', 'type': 'BACKGROUND', '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.'}, {'pmid': '23794256', 'type': 'BACKGROUND', '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.'}, {'pmid': '8817354', 'type': 'BACKGROUND', '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.'}, {'pmid': '23364010', 'type': 'BACKGROUND', '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.'}, {'pmid': '8901786', 'type': 'BACKGROUND', '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."}, {'pmid': '10490780', 'type': 'BACKGROUND', '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.'}, {'pmid': '24112443', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '29868914', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The Visceral Adiposity Measurement and Observation Study', 'detailedDescription': '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\n\nAlthough 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.\n\nBecause 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The overall study population will include all participants who provide informed consent, are enrolled in the study, and complete all study procedures as required.\n\nThe cardiovascular risk analysis population will not include participants who have history of CVD (myocardial infarction, cerebrovascular accident, heart failure, or atrial fibrillation).\n\nDiagnosis 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).', 'genderDescription': 'Sex will be defined by sex assigned at birth.\n\nGender will be by self-declared gender identity. Thus:\n\n* Men will include cis-identified males and trans men.\n* Women will include cis-identified women and trans women.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult, ≥18 years\n2. HIV+, on continuous ART for ≥12 months\n3. ≥3 years since initiation of ART\n4. 20.0 ≤ BMI ≤ 40.0 kg/m2\n\nExclusion Criteria:\n\n1. Detectable HIV plasma viremia 12 months prior enrollment, defined by ≥1 measurement of HIV-1 ribonucleic acid (RNA) \\> 1000/mL\n2. Unable or unwilling to undergo any study procedures\n3. Known hepatic cirrhosis\n4. Active hepatitis C within past 12 months, defined by detectable hepatitis C RNA\n5. Hepatitis B positive\n6. Current pregnancy or breastfeeding\n7. History of liver transplant\n8. Self-reported weekly alcohol consumption meets National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for problematic drinking (binge or chronic daily intake)\n9. Any active malignancy, excluding non-melanoma skin cancer\n10. Patient has been treated with tesamorelin or human growth hormone within the last 12 months\n11. Patient has used insulin in the previous year\n12. Patient has undergone bariatric surgery in the year prior to enrollment or is currently undergoing a weight loss program'}, 'identificationModule': {'nctId': 'NCT05383456', 'acronym': 'VAMOS', 'briefTitle': 'The Visceral Adiposity Measurement and Observation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theratechnologies'}, 'officialTitle': 'The Visceral Adiposity Measurement and Observation Study', 'orgStudyIdInfo': {'id': 'TH9507-CTR-1030'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Diagnostic Test: Diagnostic Test', 'Drug: HIV Anti-retroviral Background Therapy']}], 'interventions': [{'name': 'Diagnostic Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CT Scan', 'Fibroscan', 'Urine and Blood testing'], 'description': 'Standard diagnostic tests.', 'armGroupLabels': ['Study Participants']}, {'name': 'HIV Anti-retroviral Background Therapy', 'type': 'DRUG', 'description': 'All participants are required be on continuous HIV Anti-retroviral Background Therapy.\n\nNo intervention on drug is part of the Study.', 'armGroupLabels': ['Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ruane Clinical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33133', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Bliss Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fight Community Health Centers', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Prism Health North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Jordan Lake, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'John Koethe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Jeffery Carr, DR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theratechnologies', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dacima Consulting', 'class': 'OTHER'}, {'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'Echosens', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}