TMAO and Atherosclerosis in HIV
Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03416257
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
737
155.7
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
737 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection
Actual Study Start Date
:
Apr 12, 2004
Actual Primary Completion Date
:
Sep 1, 2013
Actual Study Completion Date
:
Apr 4, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| WIHS Women's Interagency HIV Study |
Other: No intervention
|
| MACS Multicenter AIDS Cohort Study |
Other: No intervention
|
Outcome Measures
Primary Outcome Measures
- incident carotid artery plaque [2011-2013]
assessed by repeated B-mode carotid artery ultrasound imaging
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Albert Einstein College of Medicine
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Qibin Qi,
Assistant Professor,
Albert Einstein College of Medicine
ClinicalTrials.gov Identifier:
NCT03416257
Other Study ID Numbers:
- 2015-5145
- K01HL129892
First Posted:
Jan 31, 2018
Last Update Posted:
Jun 14, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: