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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 because the information has not been verified recently.
Verified December 2009 by Tufts University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00846599
First received: February 17, 2009
Last updated: December 2, 2009
Last verified: December 2009

February 17, 2009
December 2, 2009
January 2008
January 2010   (final data collection date for primary outcome measure)
To measure flow-mediated dilation before and after eating the two study meals. [ Time Frame: Study visit 1 and 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00846599 on ClinicalTrials.gov Archive Site
To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.

  • HIV Infection
  • Cardiovascular Risk
  • HIV Infections
  • Other: Omega-3 study meal
    Participant will eat a study meal high in omega-3 fatty acids.
  • Other: Saturated fat study meal
    Participant will eat a study meal high in saturated fat.
  • 1
    High omega-3
    Intervention: Other: Omega-3 study meal
  • 2
    High saturated fat
    Intervention: Other: Saturated fat study meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact: Mari Imai 617-636-3496 cindy.imai@tufts.edu
United States
 
NCT00846599
SUB730
No
Alexandra Mangili, MD, MPH, Tufts University School of Medicine
Tufts University
Not Provided
Principal Investigator: Alexandra Mangili, MD, MPH Tufts University School of Medicine
Tufts University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP