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Niacin, N-3 Fatty Acids and Insulin Resistance

NCT00286234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-10-26

Study results available
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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.

Conditions

  • Metabolic Syndrome
  • Hypertriglyceridemia

Interventions

DRUG

omega-3 acid ethyl esters

4 q qd

DRUG

extended release niacin

2 g qpm

DRUG

placebo

omacor placebo plus niaspan placebo

DRUG

omega-3 acid ethyl esters

4 g qd

DRUG

combined treatment

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of South Dakota

    lead OTHER

Principal Investigators

  • William S Harris, PhD · Sanford Research/USD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-08-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286234 on ClinicalTrials.gov