Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT01301794
Status:
UNKNOWN
Last Update Posted:
2013-02-25
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lovaza Mechanisms of Action
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
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:
High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.
Detailed Description:
This study will investigate changes in lipid and other metabolic parameters as well as the ability of isolated lipoproteins to activate PPARs in the presence or absence of lipoprotein lipase in a cohort of normal healthy individuals with modest hypertriglyceridemia before and after a course of Lovaza.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: