- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416257
TMAO and Atherosclerosis in HIV
June 12, 2018 updated by: Qibin Qi, Albert Einstein College of Medicine
Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection
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).
Study Overview
Study Type
Observational
Enrollment (Actual)
737
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
WIHS
Women's Interagency HIV Study
|
|
MACS
Multicenter AIDS Cohort Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incident carotid artery plaque
Time Frame: 2011-2013
|
assessed by repeated B-mode carotid artery ultrasound imaging
|
2011-2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2004
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
April 4, 2017
Study Registration Dates
First Submitted
January 24, 2018
First Submitted That Met QC Criteria
January 24, 2018
First Posted (Actual)
January 31, 2018
Study Record Updates
Last Update Posted (Actual)
June 14, 2018
Last Update Submitted That Met QC Criteria
June 12, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-5145
- K01HL129892 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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