Brief Summary
In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without HIV infection from the WIHS (Women Interagency HIV Study) and MACS (Multicenter Aids Cohort Study).
Brief Title
TMAO and Atherosclerosis in HIV
Categories
Completion Date
Completion Date Type
Actual
Conditions
Carotid Artery Plaque
Eligibility Criteria
Inclusion Criteria:
* participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
Exclusion Criteria:
* a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
* participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
Exclusion Criteria:
* a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
Inclusion Criteria
Inclusion Criteria:
* participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
* participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT03416257
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-5145
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection
Primary Outcomes
Outcome Description
assessed by repeated B-mode carotid artery ultrasound imaging
Outcome Measure
incident carotid artery plaque
Outcome Time Frame
2011-2013
Secondary Ids
Secondary Id
K01HL129892
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
A total of 737 women and men with available baseline plasma choline metabolite data were included in this analysis. There were 520 HIV-infected (291 women, 229 men) and 217 HIV-uninfected (107 women, 110 men) participants included in this study. Baseline characteristics are shownin Table 1. HIV-infected and HIV-uninfected participants were generally similar in terms of demographic and behavioral variables, although HIV-infected participants were more likely to have a history of HCV infection. In addition, HIV-infected participants had lower total cholesterol and HDL cholesterol levels compared to those without HIV infection. The majority of HIV-infected individuals reported using potent ART at baseline (74% in women and 83% in men), and 46% of women and 66% of men had undetectable HIV-1 viral load (≤80 copies/mL). Compared to men, women were younger, more likely to be of black race or Hispanice thnicity and current smokers, and have a history of HCV infection and higher BMI.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Qibin Qi
Investigator Email
qibin.qi@einsteinmed.org
Investigator Phone