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

Study Overview
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Brief Summary
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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
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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 To correlate visceral fat with simple clinical parameters, including BMI and waist circumference. To compare measures of visceral fat between PLHIV with and without NAFLD.

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

Conditions
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Visceral Steatosis, Hiv, NAFLD

Intervention / Treatment
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* Device: Bone densitometry
* Other: Questionnaires
* Device: Review of medical chart


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV with NAFLD<br>HIV Nonalcoholic fatty liver disease patients | Device: Bone densitometry<br>* 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.<br>* Other names: DXA;Other: Questionnaires<br>* 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<br>Device: Review of medical chart<br>* History of previous liver diseases including hepatitis B, C, and HIV<br>|
| Active Comparator: HIV without NAFLD<br>HIV without Nonalcoholic fatty liver disease patients | Device: Bone densitometry<br>* 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.<br>* Other names: DXA;Other: Questionnaires<br>* 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<br>Device: Review of medical chart<br>* History of previous liver diseases including hepatitis B, C, and HIV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |