ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal

This study is ongoing, but not recruiting participants.

Sponsored by: National Center for Research Resources (NCRR)
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00005117
  Purpose

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 Intervention
Heart Diseases
Drug: pravastatin

MedlinePlus related topics:   Heart Diseases   

ChemIDplus related topics:   Pravastatin    Pravastatin sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control
  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005117

Locations
United States, Colorado
4200 E. 9th Avenue, Box B133    
      Denver, Colorado, United States, 80262

Sponsors and Collaborators
  More Information

Study ID Numbers:   NCRR-M01RR00051-1162, M01RR00051
First Received:   April 18, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005117
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Pravastatin
Heart Diseases

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers