Niacin, N-3 Fatty Acids and Insulin Resistance
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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 |
- Serum TG and HDL-C [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
- 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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 40 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, South Dakota | |
| Sanford Clinic Clinical Research Services | |
| Sioux Falls, South Dakota, United States, 57105 | |
| 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 May 19, 2013