Niacin, N-3 Fatty Acids and Insulin Resistance

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00286234
First received: February 2, 2006
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.


Condition Intervention Phase
Metabolic Syndrome
Hypertriglyceridemia
Drug: omega-3 acid ethyl esters
Drug: extended release niacin
Drug: placebo
Drug: combined treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Niacin, N-3 Fatty Acids and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Serum TG and HDL-C [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity, postprandial triglyceridemia, peripheral arterial tonometry [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Dual placebo
Drug: placebo
omacor placebo plus niaspan placebo
Experimental: 2
niaspan
Drug: extended release niacin
2 g qpm
Other Name: niaspan
Experimental: 3
lovaza
Drug: omega-3 acid ethyl esters
4 q qd
Other Name: lovaza omacor
Drug: omega-3 acid ethyl esters
4 g qd
Other Name: lovaza omacor
Experimental: 4
combined therapy
Drug: combined treatment
omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
Other Names:
  • lovaza, omacor
  • niaspan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

40 and 69 years of age Male or female (without hormonal cycling as described below) BMI > 25 Fasting serum triglycerides > 150 mg/dL Ratio of TG/HDL-C > 3.5

Exclusion Criteria:

BMIs > 40 kg/m2 TG > 750 mg/dL HDL-C < 10 mg/dL Presence of other secondary causes of dyslipidemia or hyperglycemia such as hepatic, renal, thyroid or other endocrine diseases History of hypersensitivity to niacin or fish oils History of gout, hepatitis, peptic ulcer or cardiovascular disease Presence of diabetes mellitus, whether controlled by diet or drugs. (We will eliminate subjects with undiagnosed diabetes by screening for fasting glucose > 126 mg/dL) Use of any dietary supplements providing more than 50 mg of niacin or 100 mg of n-3 FA Use of any herbal preparations or weight-loss products Taking any lipid-lowering drugs for at least four weeks prior to screening for the study Medically-required treatment with nitrates, calcium channel blockers, or adrenergic blocking agents (per the Niaspan package insert) Hemoglobin < 12 g/dL (owing to the significant amount of blood being drawn) LDL-C > 145 mg/dL. (This restriction will prevent the randomization of any subject whose LDL-C levels, if assigned to an n-3 FA group, might rise by 10% and thus exceed 160 mg/dL) Known substance abuse Participation in a clinical drug trial anytime during the 30 days prior to screening Anyone whom the investigators judge to be a poor candidate

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286234

Locations
United States, South Dakota
Sanford Clinic Clinical Research Services
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Investigators
Principal Investigator: William S Harris, PhD Sanford Research/USD
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William S. Harris, Sanford Research/USD
ClinicalTrials.gov Identifier: NCT00286234     History of Changes
Other Study ID Numbers: DK61486 (completed)
Study First Received: February 2, 2006
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
triglycerides
HDL-cholesterol
insulin resistance
omega-3 fatty acids
niacin

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

ClinicalTrials.gov processed this record on April 17, 2014