Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

NCT00304993 | Completed Phase 4

• 1 other identifier: SNARED
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X; Insulin Resistance

Keywords

fenofibrate; niacin; rosiglitazone; LDL phenotype pattern B; small, dense LDL; insulin resistance; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• The effect of treatment on Peak LDL particle size

Secondary Outcomes (6)

• 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

Interventions

fenofibrate DRUG

niacin DRUG

rosiglitazone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Foundation Research, Florida: lead
• GlaxoSmithKline: collaborator
• Kos Pharmaceuticals: collaborator
• Abbott: collaborator

Study Sites (1)

Foundation Research

St. Petersburg, Florida, 33705, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Cerebral Palsy

Interventions

Fenofibrate; Niacin; Rosiglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Michael E McIvor, MD

  Foundation Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 21, 2006
• Study Start: January 1, 2001
• Study Completion: February 1, 2005
• Last Updated: March 21, 2006

Record last verified: 2006-03

Locations

US (1)