Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD (Theratech)
Primary Purpose
Visceral Steatosis, Hiv, NAFLD
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bone densitometry
Questionnaires
Review of medical chart
Sponsored by
About this trial
This is an interventional health services research trial for Visceral Steatosis
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.
Sites / Locations
- McGill University Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HIV with NAFLD
HIV without NAFLD
Arm Description
HIV Nonalcoholic fatty liver disease patients
HIV without Nonalcoholic fatty liver disease patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05359471
First Posted
April 22, 2022
Last Updated
April 28, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT05359471
Brief Title
Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD
Acronym
Theratech
Official Title
Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Steatosis, Hiv, NAFLD
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIV with NAFLD
Arm Type
Active Comparator
Arm Description
HIV Nonalcoholic fatty liver disease patients
Arm Title
HIV without NAFLD
Arm Type
Active Comparator
Arm Description
HIV without Nonalcoholic fatty liver disease patients
Intervention Type
Device
Intervention Name(s)
Bone densitometry
Other Intervention Name(s)
Dual-energy x ray absorptiometry, DEXA, DXA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Review of medical chart
Intervention Description
History of previous liver diseases including hepatitis B, C, and HIV
Primary Outcome Measure Information:
Title
Determination of visceral fat
Description
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.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giada Sebastiani
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD
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