Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005117
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-18
Brief Title:
Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000051 | NIH | None | httpsreporternihgovquickSearchM01RR000051 |