Overview

Niacin, N-3 Fatty Acids and Insulin Resistance

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of South Dakota
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Insulin
Niacin
Niacinamide
Nicotinic Acids
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