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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00005117
First received: April 18, 2000
Last updated: June 23, 2005
Last verified: November 2001
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014