Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD

NCT05359471 | Unknown

• 1 other identifier: 2021-6656
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the distribution of visceral fat in people living with HIV (PLHIV) with NAFLD by clinical anthropometric indicators (wais-to-hip ratio), lipid accumulation product (waist circumference and triglycerides) and radiological techniques such as dual-energy X-ray absorptiometry (DXA) (trunk fat mass and fat mass through dual-energy X-ray absorptiometry).

Conditions

Visceral Steatosis; Hiv; NAFLD

Outcome Measures

Primary Outcomes (1)

• Determination of visceral fat

  Outcome Measures The primary outcome is the presence of high visceral fat, defined as \>35% total body fat for females and \>25% total body fat for males.

  Through study completion, an average of 1 year

Study Arms (2)

HIV with NAFLD

ACTIVE COMPARATOR

HIV Nonalcoholic fatty liver disease patients

Device: Bone densitometry; Other: Questionnaires; Device: Review of medical chart

HIV without NAFLD

ACTIVE COMPARATOR

HIV without Nonalcoholic fatty liver disease patients

Device: Bone densitometry; Other: Questionnaires; Device: Review of medical chart

Interventions

Bone densitometry DEVICE

It is the standard method for diagnosing osteoporosis. In the central DXA examination, which measures bone density of the hip and spine, the patient lies on a padded table.

Also known as: Dual-energy x ray absorptiometry, DEXA, DXA

HIV with NAFLD; HIV without NAFLD

Questionnaires OTHER

Smoking and drug related questionnaires will be used as variable to see dependence, how it impacts participants activities/health or determining whether they are light/moderate/heavy smoker

HIV with NAFLD; HIV without NAFLD

Review of medical chart DEVICE

History of previous liver diseases including hepatitis B, C, and HIV

HIV with NAFLD; HIV without NAFLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old at screening;
• Able to provide informed consent, in French or English;
• Historical HIV seropositive (ELISA with Western blot confirmation);

You may not qualify if:

• Contraindications to Fibroscan with CAP (pregnant women or individuals carrying a pacemaker);
• Historical evidence of co-infection with Hepatitis B or C (i.e. HBsAg or anti-HCV positive);
• Significant alcohol intake (\>21 units/week in men and \>14 units/week in women\[23\]) at screening using the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire;
• Patients with previous decompensating events from liver cirrhosis (Child-Pugh B and C), hepatocellular carcinoma, liver transplantation.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Fatty Liver; Acquired Immunodeficiency Syndrome; Non-alcoholic Fatty Liver Disease

Interventions

Absorptiometry, Photon; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; HIV Infections; 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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Giada Sebastiani

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist at the Research Institute of McGill University

Model Details: This is single center, cross sectional study conducted at the Chronic Viral Illness Service (CVIS) of McGill University Health Center (MUHC). This is a pilot feasibility study with the aim of further exploring more options to conduct or facilitate similar studies in larger group.

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 3, 2022
• Study Start: April 9, 2021
• Primary Completion: April 19, 2022
• Study Completion: June 1, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

CA (1)