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

Hiv Clinical Trial

— Theratech  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05359471
• Other study ID #: 2021-6656
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Hiv
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Visceral Steatosis

Intervention

Device:
• Bone densitometry
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.

Other:
• Questionnaires
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

Device:
• Review of medical chart
History of previous liver diseases including hepatitis B, C, and HIV

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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