Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Kos Pharmaceuticals
Abbott
Information provided by:
Foundation Research, Florida
ClinicalTrials.gov Identifier:
NCT00304993
First received: March 17, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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
Metabolic Syndrome X
Insulin Resistance
Drug: fenofibrate
Drug: niacin
Drug: rosiglitazone
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Foundation Research, Florida:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: January 2001
Estimated Study Completion Date: February 2005
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..

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304993

Locations
United States, Florida
Foundation Research
St. Petersburg, Florida, United States, 33705
Sponsors and Collaborators
Foundation Research, Florida
GlaxoSmithKline
Kos Pharmaceuticals
Abbott
Investigators
Principal Investigator: Michael E McIvor, MD Foundation Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304993     History of Changes
Other Study ID Numbers: SNARED
Study First Received: March 17, 2006
Last Updated: March 17, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Foundation Research, Florida:
fenofibrate
niacin
rosiglitazone
LDL phenotype pattern B
small, dense LDL
insulin resistance
Metabolic Syndrome

Additional relevant MeSH terms:
Dyslipidemias
Insulin Resistance
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Fenofibrate
Niacin
Niacinamide
Nicotinic Acids
Rosiglitazone
Antimetabolites
Cardiovascular Agents
Growth Substances
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014