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NCT00931879 · ClinicalTrials.gov registry record · Phase 4
Lovaza® and Microvascular Function in Type 2 Diabetes
A Phase 4 study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT00931879 is a Phase 4 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 44 participants.
The verdict
NCT00931879, a Phase 4 study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
The objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza® on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy and elevated triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on vascular function that are independent of the changes in serum triglycerides. The efficacy will be compared with a placebo given at the same duration. Efficacy of the drug will be evaluated after 3 and 6 months of treatment. This timeline should be adequate for evaluation of the primary neurophysiological endpoints. Previously, the investigators have demonstrated that it is feasible to pharmacologically alter nerve fiber density in as little as 18 weeks and that this correlates with subjective and objective measures of neurovascular function. The investigators are predicting an enhancement of post-ischemic hyperemia of the foot dorsum, where the dilative mechanism is primarily endothelium-dependent and a similar improvement in heat-induced hyperemia.
Interventions
- DRUG Placebo
- DRUG omega-3-ethyl esters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00931879
The ClinicalTrials.gov registry entry for NCT00931879 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Virginia Medical School, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00931879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00931879 about?
NCT00931879 is a clinical study titled "Lovaza® and Microvascular Function in Type 2 Diabetes". The objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza® on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy and elevated triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on vascular function that a...
What is the current status of trial NCT00931879?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2009-10. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00931879?
The interventions under investigation include: Placebo (DRUG), omega-3-ethyl esters (DRUG).
Who is sponsoring clinical trial NCT00931879?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
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