Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05383456
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-04-08
Brief Title:
The Visceral Adiposity Measurement and Observation Study
Sponsor:
Theratechnologies
Organization:
Theratechnologies
Study Overview
Official Title:
The Visceral Adiposity Measurement and Observation Study
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAMOS
Brief Summary:
The Visceral Adiposity Measurement and Observation Study
Detailed Description:
Visceral adiposity VA is a form of ectopic fat deposition that correlates with cardiometabolic risk in both the general population and among people with human immunodeficiency virus HIV PWH1 Excess VA EVA is prevalent among PWH23 and prevalence rises with age and time on antiretroviral treatment3 Effective plasma virologic suppression is not protective against EVA and associated comorbidities possibly due to adverse metabolic effects of certain antiretroviral agents the low-level expression of HIV gene products within the adipose tissue and other factos4
Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy ART23 it may go unrecognized or be mischaracterized as generalized obesity Whereas obesity and EVA both increase waist circumference WC they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots whereas individuals with EVA accumulate fat within the abdominal cavity Ectopic fat accumulation EFA also occurs at various other depots namely around and within various internal organs eg the heart skeletal muscle liver and pancreas15 For purposes of the VAMOS study EFA is defined as the amount of pericardial fat skeletal muscle fat and liver fat the VAMOS study subjects have VA for the VAMOS study is held separately as it is the primary endpoint
Because it represents a potentially modifiable cardiovascular risk factor among PWH simple practical surrogate markers are needed to identify patients with probable EVA Anthropometric measurements such as WC correlate with EVA in the general population1 but their predictive value is less well defined for subgroups of PWH
Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy ART23 it may go unrecognized or be mischaracterized as generalized obesity Whereas obesity and EVA both increase waist circumference WC they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots whereas individuals with EVA accumulate fat within the abdominal cavity Ectopic fat accumulation EFA also occurs at various other depots namely around and within various internal organs eg the heart skeletal muscle liver and pancreas15 For purposes of the VAMOS study EFA is defined as the amount of pericardial fat skeletal muscle fat and liver fat the VAMOS study subjects have VA for the VAMOS study is held separately as it is the primary endpoint
Because it represents a potentially modifiable cardiovascular risk factor among PWH simple practical surrogate markers are needed to identify patients with probable EVA Anthropometric measurements such as WC correlate with EVA in the general population1 but their predictive value is less well defined for subgroups of PWH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None