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Sponsors and Collaborators: |
Foundation Research, Florida GlaxoSmithKline Kos Pharmaceuticals Abbott |
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Information provided by: | Foundation Research, Florida |
ClinicalTrials.gov Identifier: | NCT00304993 |
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.
Condition | Intervention | Phase |
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Metabolic Syndrome X Insulin Resistance |
Drug: fenofibrate Drug: niacin Drug: rosiglitazone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia |
Estimated Enrollment: | 30 |
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..
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Foundation Research | |
St. Petersburg, Florida, United States, 33705 |
Principal Investigator: | Michael E McIvor, MD | Foundation Research |
Study ID Numbers: | SNARED |
Study First Received: | March 17, 2006 |
Last Updated: | March 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00304993 |
Health Authority: | United States: Institutional Review Board |
fenofibrate niacin rosiglitazone LDL phenotype pattern B |
small, dense LDL insulin resistance Metabolic Syndrome |
Metabolic Syndrome X Metabolic Diseases Procetofen Insulin Hyperinsulinism Nicotinic Acids Syndrome X Insulin Resistance |
Glucose Metabolism Disorders Metabolic disorder Niacin Rosiglitazone Dyslipidemias Abdominal obesity metabolic syndrome Lipid Metabolism Disorders |
Antimetabolites Vasodilator Agents Disease Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs |
Cardiovascular Agents Pharmacologic Actions Hypoglycemic Agents Pathologic Processes Syndrome Therapeutic Uses Vitamins Micronutrients |