Clinical trial NCT05359471: Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD
Official title: Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visceral Steatosis
Hiv
NAFLD
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determination of visceral fat
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Giada Sebastiani
role: PRINCIPAL_INVESTIGATOR
References: