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NCT00166036 · ClinicalTrials.gov registry record · Phase 2
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
A Phase 2 study of Diabetes Mellitus and Hypercholesterolemia, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00166036: Completed Phase 2 study of Diabetes Mellitus and Hypercholesterolemia, sponsored by Emory University.
NCT00166036 is a Phase 2 study of Diabetes Mellitus and Hypercholesterolemia that has completed, run by Emory University. The registered enrollment target is 36 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00166036, a Phase 2 study of Diabetes Mellitus and Hypercholesterolemia, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances \[TBARS\], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.
Primary Outcome
Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.
Conditions Studied
Interventions
- DRUG Atorvastatin
- DRUG Pravastatin
Study Locations (1)
Georgia
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00166036 record still lists
NCT00166036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Atorvastatin is the first listed.
NCT00166036 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT00166036 about?
NCT00166036 is a clinical study titled "Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells". Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances \[TBARS\],...
What is the current status of trial NCT00166036?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2004-09. Estimated completion is 2009-04.
What conditions does trial NCT00166036 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Hypercholesterolemia, Metabolic Syndrome X.
What interventions are being tested in trial NCT00166036?
The interventions under investigation include: Atorvastatin (DRUG), Pravastatin (DRUG).
Who is sponsoring clinical trial NCT00166036?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00166036 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00166036's enrollment target sits among peer trials
36 173rd of 208 higher than 36 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus 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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