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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ] [ Designated as safety issue: No ]

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
Genders 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
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:
No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
HIV
human immunodeficiency virus
brachial artery ultrasound
brachial artery reactivity
cardiovascular risk
omega three
saturated fat
sustiva
atripla
kaletra
treatment naive

Additional relevant MeSH terms:
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 April 17, 2014