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Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304993
First Posted: March 21, 2006
Last Update Posted: March 21, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
GlaxoSmithKline
Kos Pharmaceuticals
Abbott
Information provided by:
Foundation Research, Florida
March 17, 2006
March 21, 2006
March 21, 2006
January 2001
Not Provided
The effect of treatment on Peak LDL particle size
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
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.

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..

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Metabolic Syndrome X
  • Insulin Resistance
  • Drug: fenofibrate
  • Drug: niacin
  • Drug: rosiglitazone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2005
Not Provided

Inclusion Criteria:

  • Age >= 18 years Fasting triglycerides > 100 mg/dL Fasting plasma glucose 110-128 mg/dL Non-pattern A LDL phenotype

Exclusion Criteria:

  • Overt diabetes mellitus Current therapy with hypoglycemic agents Secondary causes of dyslipidemia (e.g. HRT, thyroid disease) Serum creatinine > 2.5 mg/dL or nephrotic syndrome AST/ALT > 3X upper limits of normal Known gallbladder disease History of gout or hyperuricemia History of peptic ulcer disease Hypersensitivity or intolerance to any of the study drugs Women who are pregnant or nursing
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00304993
SNARED
Not Provided
Not Provided
Not Provided
Not Provided
Foundation Research, Florida
  • GlaxoSmithKline
  • Kos Pharmaceuticals
  • Abbott
Principal Investigator: Michael E McIvor, MD Foundation Research
Foundation Research, Florida
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP