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Niacin, N-3 Fatty Acids and Insulin Resistance

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ClinicalTrials.gov Identifier: NCT00286234
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : May 1, 2013
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
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 or disease Intervention/treatment Phase
Metabolic Syndrome Hypertriglyceridemia Drug: omega-3 acid ethyl esters Drug: extended release niacin Drug: placebo Drug: combined treatment Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Niacin, N-3 Fatty Acids and Insulin Resistance
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Serum TG and HDL-C [ Time Frame: baseline and 4 months ]

Secondary Outcome Measures :
  1. Insulin sensitivity, postprandial triglyceridemia, peripheral arterial tonometry [ Time Frame: baseline and 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


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 ClinicalTrials.gov identifier (NCT number): NCT00286234


Locations
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United States, South Dakota
Sanford Clinic Clinical Research Services
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: William S Harris, PhD Sanford Research/USD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William S. Harris, Sanford Research/USD
ClinicalTrials.gov Identifier: NCT00286234     History of Changes
Other Study ID Numbers: DK61486 (completed)
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013
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:
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Metabolic Syndrome
Insulin Resistance
Hypertriglyceridemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Niacin
Niacinamide
Nicotinic Acids
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances