Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
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.
Metabolic Syndrome X
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia|
- The effect of treatment on Peak LDL particle size
- The effect of treatment on:
- traditional lipid parameters (LDL-C, HDL-C, triglycerides)
- % of lipids in regions IIIa+IIIb of a gradient gel electrophoresis
- LDL phenotype
- fasting glucose
- Hemoglobin A1c
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||February 2005|
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 statin+fenofibrate+niacin, or statin+fenofibrate+rosiglitazone for six months, at which time lipid phenotype will again be determined..
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304993
|United States, Florida|
|St. Petersburg, Florida, United States, 33705|
|Principal Investigator:||Michael E McIvor, MD||Foundation Research|