Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

Completed · Phase 4

Conditions studied: Metabolic Syndrome X, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00304993

Run by

Foundation Research, Florida

People needed

30

Starts

2001-01-01

Expected to finish

2005-02-01

Last updated by the study team

2006-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Foundation Research — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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