Characterization of Visceral Adiposity in HIV Mono-infected Patients With NAFLD
NCT ID: NCT05359471
Last Updated: 2022-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-04-09
2022-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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HIV with NAFLD
HIV Nonalcoholic fatty liver disease patients
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.
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
Review of medical chart
History of previous liver diseases including hepatitis B, C, and HIV
HIV without NAFLD
HIV without Nonalcoholic fatty liver disease patients
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.
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
Review of medical chart
History of previous liver diseases including hepatitis B, C, and HIV
Interventions
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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.
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
Review of medical chart
History of previous liver diseases including hepatitis B, C, and HIV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent, in French or English;
* Historical HIV seropositive (ELISA with Western blot confirmation);
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Giada Sebastiani
Clinical Scientist at the Research Institute of McGill University
Principal Investigators
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Giada Sebastiani
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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McGill University Health Center
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2021-6656
Identifier Type: -
Identifier Source: org_study_id
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