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Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men (PERTH)

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ClinicalTrials.gov Identifier: NCT00846599
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : October 12, 2017
Sponsor:
Information provided by:
Tufts University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
HIV Infection Cardiovascular Risk HIV Infections Other: Omega-3 study meal Other: Saturated fat study meal

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
Study Start Date : January 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. To measure flow-mediated dilation before and after eating the two study meals. [ Time Frame: Study visit 1 and 2 ]

Secondary Outcome Measures :
  1. To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ]

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846599


Locations
United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Alexandra Mangili, MD, MPH Tufts University School of Medicine
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
PERTH Study  This link exits the ClinicalTrials.gov site

Responsible Party: Alexandra Mangili, MD, MPH, Tufts University School of Medicine
ClinicalTrials.gov Identifier: NCT00846599     History of Changes
Other Study ID Numbers: SUB730
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

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