TMAO and Atherosclerosis in HIV
Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection
2 other identifiers
observational
737
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2004
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedJune 14, 2018
June 1, 2018
9.4 years
January 24, 2018
June 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
incident carotid artery plaque
assessed by repeated B-mode carotid artery ultrasound imaging
2011-2013
Study Arms (2)
WIHS
Women's Interagency HIV Study
MACS
Multicenter AIDS Cohort Study
Interventions
Eligibility Criteria
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.
You may qualify if:
- participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).
You may not qualify if:
- a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 24, 2018
First Posted
January 31, 2018
Study Start
April 12, 2004
Primary Completion
September 1, 2013
Study Completion
April 4, 2017
Last Updated
June 14, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share