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Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men (PERTH)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Tufts University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Tufts University
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00846599
First received: February 17, 2009
Last updated: December 2, 2009
Last verified: December 2009
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Purpose
The purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.
| Condition | Intervention |
|---|---|
| HIV Infection Cardiovascular Risk HIV Infections | Other: Omega-3 study meal Other: Saturated fat study meal |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men |
Resource links provided by NLM:
Further study details as provided by Tufts University:
Primary Outcome Measures:
- To measure flow-mediated dilation before and after eating the two study meals. [ Time Frame: Study visit 1 and 2 ]
Secondary Outcome Measures:
- To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
High omega-3
|
Other: Omega-3 study meal
Participant will eat a study meal high in omega-3 fatty acids.
|
|
2
High saturated fat
|
Other: Saturated fat study meal
Participant will eat a study meal high in saturated fat.
|
Detailed Description:
This study requires two visits. Once determined eligible by the study criteria, during the first visit the participant will be randomly placed to receive one of two high-fat meals. The participant will receive the other study meal during the second visit. At each visit, brachial artery ultrasounds will be performed before and 3 hours after the meal is eaten. The sample size is 50 subjects. This study will be conducted at the Clinical Research Center at Tufts Medical Center.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.
Criteria
Inclusion Criteria:
- HIV-positive white male aged >18 years
-
Under one of the following treatment categories:
- Treatment naive or have never taken any HIV medications
- Taking Kaletra
- Taking Sustiva
- Taking Atripla
Exclusion Criteria:
- Smoker
-
Pre-existing diagnosis or treatment for the following:
- Lipid disorder
- Cardiovascular disease
- High blood pressure
- Diabetes
- Acute opportunistic infection or malignancy within last 3 months or current therapy for either
- Active IV drug use
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846599
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846599
Contacts
| Contact: Mari Imai | 617-636-3496 | cindy.imai@tufts.edu |
Locations
| United States, Massachusetts | |
| Tufts University | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: Alexandra Mangili, MD, MPH | |
Sponsors and Collaborators
Tufts University
Investigators
| Principal Investigator: | Alexandra Mangili, MD, MPH | Tufts University School of Medicine |
More Information
Additional Information:
| Responsible Party: | Alexandra Mangili, MD, MPH, Tufts University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00846599 History of Changes |
| Other Study ID Numbers: |
SUB730 |
| Study First Received: | February 17, 2009 |
| Last Updated: | December 2, 2009 |
Keywords provided by Tufts University:
|
brachial artery ultrasound brachial artery reactivity HIV human immunodeficiency virus cardiovascular risk omega three |
saturated fat sustiva atripla kaletra treatment naive |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on September 19, 2017