CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 68 enrolled
Drug / intervention
omega-3 acid ethyl esters +4 moredrug
Likely dose
extended release niacin 2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00286234
NCT00286234Phase 4Completed
CompareCT.gov

Niacin, N-3 Fatty Acids and Insulin Resistance

University of South Dakota·interventional·Posted Feb 3, 2006·Updated Oct 26, 2021

In Brief

A Phase 4 clinical trial evaluating omega-3 acid ethyl esters, extended release niacin, and 2 other interventions for Metabolic Syndrome and Hypertriglyceridemia. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome, Hypertriglyceridemia
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2006
Enrollment StartOct 1, 2007
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.4 years ago

Interventions

omega-3 acid ethyl estersdrug

4 q qd

extended release niacindrug

2 g qpm

placebodrug

omacor placebo plus niaspan placebo

omega-3 acid ethyl estersdrug

4 g qd

combined treatmentdrug

omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm