Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304993
Status:
COMPLETED
Last Update Posted:
2006-03-21
First Post:
2006-03-17
Brief Title:
Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Sponsor:
Foundation Research Florida
Organization:
Foundation Research Florida
Study Overview
Official Title:
Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
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:
Lipid abnormalities in people with the Metabolic Syndrome the Insulin Resistance Syndrome are characterized by elevations in triglycerides and LDL cholesterol low levels of HDL cholesterol and small dense LDL particles Statins generally do not change LDL particle size so often fenofibrate is added This combination may still not be sufficient Niacin is a common third drug added to the treatment regimen but niacin can increase insulin resistance This study compares niacin as a third drug to rosiglitazone an insulin sensitizer
Detailed Description:
The Metabolic Syndrome is characterized by an atherogenic dyslipidemia consisting of hypertriglyceridemia modest elevations of LDL cholesterol low levels of HDL cholesterol and LDL phenotype pattern B small dense LDL particles Statins are first line therapy and reduce LDL cholesterol levels without affecting LDL particle size Fenofibrate addresses the triglycerides HDL cholesterol levels and LDL phenotype so is recommended as second level therapy The third element is niacin but for insulin resistant patients a question has been whether niacin might be exacerbating the underlying pathophysiology of Metabolic Syndrome patients In SNARED niacin was compared to the insulin sensitizer rosiglitazone in study subjects already on statin and fenofibrate
All volunteers participating in SNARED exhibit LDL phenotype pattern B despite statin therapy at the time of recruitment Comparisons of LDL phenotype at baseline are to be compared to measurements made after 4 months of statin fenofibrate If the LDL phenotype converts to pattern A large LDL particles this is a study endpoint Otherwise study subjcts are randomized to receive statinfenofibrateniacin or statinfenofibraterosiglitazone for six months at which time lipid phenotype will again be determined
All volunteers participating in SNARED exhibit LDL phenotype pattern B despite statin therapy at the time of recruitment Comparisons of LDL phenotype at baseline are to be compared to measurements made after 4 months of statin fenofibrate If the LDL phenotype converts to pattern A large LDL particles this is a study endpoint Otherwise study subjcts are randomized to receive statinfenofibrateniacin or statinfenofibraterosiglitazone for six months at which time lipid phenotype will again be determined
Study Oversight
Has Oversight DMC:
None
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?:
None