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Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

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. Identifier: NCT00304993
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : March 21, 2006
Kos Pharmaceuticals
Information provided by:
Foundation Research, Florida

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Insulin Resistance Drug: fenofibrate Drug: niacin Drug: rosiglitazone Phase 4

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 statin+fenofibrate+niacin, or statin+fenofibrate+rosiglitazone for six months, at which time lipid phenotype will again be determined..

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Study Start Date : January 2001
Study Completion Date : February 2005

Primary Outcome Measures :
  1. The effect of treatment on Peak LDL particle size

Secondary Outcome Measures :
  1. The effect of treatment on:
  2. traditional lipid parameters (LDL-C, HDL-C, triglycerides)
  3. % of lipids in regions IIIa+IIIb of a gradient gel electrophoresis
  4. LDL phenotype
  5. fasting glucose
  6. Hemoglobin A1c

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 0 Years
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304993

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United States, Florida
Foundation Research
St. Petersburg, Florida, United States, 33705
Sponsors and Collaborators
Foundation Research, Florida
Kos Pharmaceuticals
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Principal Investigator: Michael E McIvor, MD Foundation Research
Layout table for additonal information Identifier: NCT00304993    
Other Study ID Numbers: SNARED
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: March 21, 2006
Last Verified: March 2006
Keywords provided by Foundation Research, Florida:
LDL phenotype pattern B
small, dense LDL
insulin resistance
Metabolic Syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex