MedDataX Logo

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

NCT ID: NCT00846599

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection Cardiovascular Risk HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

brachial artery ultrasound brachial artery reactivity HIV human immunodeficiency virus cardiovascular risk omega three saturated fat sustiva atripla kaletra treatment naive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

High omega-3

Omega-3 study meal

Intervention Type OTHER

Participant will eat a study meal high in omega-3 fatty acids.

2

High saturated fat

Saturated fat study meal

Intervention Type OTHER

Participant will eat a study meal high in saturated fat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omega-3 study meal

Participant will eat a study meal high in omega-3 fatty acids.

Intervention Type OTHER

Saturated fat study meal

Participant will eat a study meal high in saturated fat.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tufts University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tufts University School of Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandra Mangili, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts University

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.tufts.edu/med/nutrition-infection/research/dom/study-perth.html

PERTH Study

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SUB730

Identifier Type: -

Identifier Source: org_study_id