Mode
Text Size
Log in / Sign up
Phase 4 Completed N=68 Randomized Quadruple-blind Treatment

Niacin, N-3 Fatty Acids and Insulin Resistance

Source: ClinicalTrials.gov NCT00286234 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Serum TG — 233; 157; 176; 156 mg/dl
◆ Published Evidence
Established
42citations · ~3 / year
Effects of prescription niacin and omega-3 fatty acids on lipids and vascular function in metabolic syndrome: a randomized controlled trial.
Journal of lipid research · 2012 · Open access · Likely link

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.

Linked Publications (3)

  • Effects of prescription niacin and omega-3 fatty acids on lipids and vascular function in metabolic syndrome: a randomized controlled trial.
    Journal of lipid research · 2012 · 42 citations · Open access · Likely link
  • Effects of niacin and omega-3 fatty acids on the apolipoproteins in overweight patients with elevated triglycerides and reduced HDL cholesterol.
    Atherosclerosis · 2015 · 34 citations · Likely link
  • Once-daily extended-release niacin lowers serum phosphorus concentrations in patients with metabolic syndrome dyslipidemia.
    American journal of kidney diseases : the official journal of the National Kidney Foundation · 2011 · 9 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Serum TG
233; 157; 176; 156
SECONDARY
Non-HDL-C
145; 155; 133; 170

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00286234) and the linked publication. 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. Informational only — not medical advice.

Back to search