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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846599
First Posted: February 18, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tufts University
  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
Study Completion Date: January 2010
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

Information from the National Library of Medicine

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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
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

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
First Submitted: February 17, 2009
First Posted: February 18, 2009
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