Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Information source: Foundation Research, Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome X; Insulin Resistance
Intervention: fenofibrate (Drug); niacin (Drug); rosiglitazone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Foundation Research, Florida Official(s) and/or principal investigator(s): Michael E McIvor, MD, Principal Investigator, Affiliation: Foundation Research
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.
Clinical Details
Official title: Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The effect of treatment on Peak LDL particle size
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Foundation Research, St. Petersburg, Florida 33705, United States
Additional Information
Starting date: January 2001
Last updated: March 17, 2006
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