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Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal

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ClinicalTrials.gov Identifier: NCT00005117
Recruitment Status : Unknown
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:
There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. It has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. Blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. This primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. Secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.

Condition or disease Intervention/treatment Phase
Heart Diseases Drug: pravastatin Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease

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): NCT00005117


Locations
United States, Colorado
4200 E. 9th Avenue, Box B133
Denver, Colorado, United States, 80262
Sponsors and Collaborators
National Center for Research Resources (NCRR)

ClinicalTrials.gov Identifier: NCT00005117     History of Changes
Other Study ID Numbers: NCRR-M01RR00051-1162
M01RR000051 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001

Keywords provided by National Center for Research Resources (NCRR):
endothelial dysfunction

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors