drugset / Trial / NCT00286234
Niacin, N-3 Fatty Acids and Insulin Resistance
Phase 4
Completed
68 enrolled
University of South Dakota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2008-08
- Completion
- 2008-12
Publications
- Savinova OV, Fillaus K, Harris WS, Shearer GC. Effects of niacin and omega-3 fatty acids on the apolipoproteins in overweight patients with elevated triglycerides and reduced HDL cholesterol. Atherosclerosis. 2015 Jun;240(2):520-5. doi: 10.1016/j.atherosclerosis.2015.04.793. Epub 2015 Apr 22.
- Shearer GC, Pottala JV, Hansen SN, Brandenburg V, Harris WS. Effects of prescription niacin and omega-3 fatty acids on lipids and vascular function in metabolic syndrome: a randomized controlled trial. J Lipid Res. 2012 Nov;53(11):2429-35. doi: 10.1194/jlr.P022392. Epub 2012 Aug 14.
- Hu S, Shearer GC, Steffes MW, Harris WS, Bostom AG. Once-daily extended-release niacin lowers serum phosphorus concentrations in patients with metabolic syndrome dyslipidemia. Am J Kidney Dis. 2011 Jan;57(1):181-2. doi: 10.1053/j.ajkd.2010.06.029. Epub 2010 Oct 8. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lovaza | Other / unclassified | 4 g | — |
| Subject | Niacin | Small molecule | 2 g | — |