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NCT00286234 · ClinicalTrials.gov registry record · Phase 4
Niacin, N-3 Fatty Acids and Insulin Resistance
A Phase 4 study, sponsored by University of South Dakota.
- Completed
- Registry status
- Phase 4
- Development phase
- 68
- Enrollment target
NCT00286234: Completed Phase 4 study, sponsored by University of South Dakota.
NCT00286234 is a Phase 4 study that has completed, run by University of South Dakota. The registered enrollment target is 68 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00286234, a Phase 4 study, has completed, sponsored by University of South Dakota.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 68 participants
- Enrollment target
Study 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.
Primary Outcome
Change From Baseline to 4 Months in Serum Triglycerides
Interventions
- DRUG placebo
- DRUG omega-3 acid ethyl esters
- DRUG extended release niacin
- DRUG combined treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00286234 record still lists
NCT00286234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00286234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00286234 about?
NCT00286234 is a clinical study titled "Niacin, N-3 Fatty Acids and Insulin Resistance". 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 rele...
What is the current status of trial NCT00286234?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2007-10. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00286234?
The interventions under investigation include: placebo (DRUG), omega-3 acid ethyl esters (DRUG), extended release niacin (DRUG), combined treatment (DRUG).
Who is sponsoring clinical trial NCT00286234?
This trial is sponsored by University of South Dakota, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00286234's enrollment target sits among peer trials
68 1076th of 2000 higher than 918 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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