Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men (PERTH)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | February 17, 2009 | ||||
| Last Updated Date | December 2, 2009 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00846599 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To compare the effect of different dietary fats on endothelial function. [ Time Frame: Study visit 1 and 2 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men | ||||
| Official Title ICMJE | Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | January 2010 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00846599 | ||||
| Other Study ID Numbers ICMJE | SUB730 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alexandra Mangili, MD, MPH, Tufts University School of Medicine | ||||
| Study Sponsor ICMJE | Tufts University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tufts University | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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