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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05359471
Acronym
Theratech
Enrollment
30
Registered
2022-05-03
Start date
2021-04-09
Completion date
2022-06-01
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral Steatosis, Hiv, NAFLD

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).

Detailed description

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.. The investigator will correlate visceral fat with simple clinical parameters, including BMI and waist circumference and comparing measures of visceral fat between PLHIV with and without NAFLD. Participants will undergo a single study visit for confirmation of eligibility. Until now, there has been no study assessing the distribution of visceral fat in PLHIV with NAFLD by clinical anthropometric indicators (WHR), lipid accumulation product (waist circumference, hip circumference and waist to hip ratio and triglycerides) and radiological techniques such as DXA. In the present feasibility pilot study, the investigator will determine the distribution of excessive fat around the abdomen(visceral fat) by DXA scan in HIV mono-infected patients with/without NAFLD to see if it will be possible to conduct a larger study.. The investigator will also correlate visceral fat with simple clinical parameters, including BMI and waist circumference and comparing measures of visceral fat between PLHIV with and without NAFLD. DXA scan Bone densitometry, also called dual-energy x-ray absorptiometry, DEXA or DXA, uses a very small dose of ionizing radiation to produce pictures of the inside of the body (usually the lower (or lumbar) spine and hips) to measure bone loss. It is commonly used to diagnose osteoporosis, to assess an individual's risk for developing osteoporotic fractures. DXA is simple, quick and noninvasive. It's also the most commonly used and the most standard method for diagnosing osteoporosis. Primary Objective In order to determine if the distribution of visceral fat in PLHIV with NAFLD by clinical anthropometric indicators (waist-to-hip ratio), lipid accumulation product (waist circumference and triglycerides) and radiological techniques such as DXA (trunk fat mass and fat mass through dual-energy X-ray absorptiometry) could be used in future larger study groups. Secondary Objectives 1. To correlate visceral fat with simple clinical parameters, including BMI and waist circumference. 2. To compare measures of visceral fat between PLHIV with and without NAFLD.

Interventions

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.

OTHERQuestionnaires

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

DEVICEReview of medical chart

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

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Determination of visceral fatThrough study completion, an average of 1 yearOutcome 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026