Phase 4 N=68 Randomized Quadruple-blind Treatment

Niacin, N-3 Fatty Acids and Insulin Resistance

Metabolic Syndrome · Hypertriglyceridemia

Bottom Line

View on ClinicalTrials.gov: NCT00286234 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Serum TG — 233; 157; 176; 156 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: omega-3 acid ethyl esters (Drug); extended release niacin (Drug); placebo (Drug); combined treatment (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of South Dakota
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum TG	233; 157; 176; 156	—
SECONDARY Non-HDL-C	145; 155; 133; 170	—

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.

Eligibility 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 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 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

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Data sourced from ClinicalTrials.gov (NCT00286234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.