Trial · NCT00166036
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
NCT00166036, Phase 2, Completed, Emory University; results first posted 2014-09-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells. Trials, record NCT00166036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00166036
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
- NCT number
- NCT00166036
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Diabetes Mellitus, Metabolic Syndrome X, Hypercholesterolemia
- Interventions
- Atorvastatin, Pravastatin
- First posted
- 2005-09-14
- Last updated
- 2014-09-08
- Results first posted
- 2014-09-08
- Limitations and caveats
- Detection of changes in Oxidative stress with significance requires a much larger cohort study.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels | Baseline &12 Weeks | 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. |
| Secondary | Change in Flow-mediated Dilatation (FMD) | Baseline & 12 Weeks | Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels | Baseline &12 Weeks | nmol/mL | MEAN | |
| SECONDARY | Change in Flow-mediated Dilatation (FMD) | Baseline & 12 Weeks | Percentage of brachial artery diameter | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels | Atorvastatin 10 mg | 2.1 | Standard Error 0.8 | nmol/mL | |
| Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels | Pravastatin 80 mg | 2.5 | Standard Error 1.0 | nmol/mL | |
| Change in Flow-mediated Dilatation (FMD) | Atorvastatin 10 mg | 5.9 | Standard Error 2.9 | Percentage of brachial artery diameter | |
| Change in Flow-mediated Dilatation (FMD) | Pravastatin 80 mg | 6.0 | Standard Error 2.3 | Percentage of brachial artery diameter |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin 10 mg | 17 | |
| Overall Study | STARTED | Pravastatin 80 mg | 19 | |
| Overall Study | COMPLETED | Atorvastatin 10 mg | 17 | |
| Overall Study | COMPLETED | Pravastatin 80 mg | 19 | |
| Overall Study | NOT COMPLETED | Atorvastatin 10 mg | 0 | |
| Overall Study | NOT COMPLETED | Pravastatin 80 mg | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin 10 mg | ||
| Total, all-cause mortality | Pravastatin 80 mg | ||
| Total, other adverse events | Atorvastatin 10 mg | 0 | 17 |
| Total, other adverse events | Pravastatin 80 mg | 0 | 19 |
| Total, serious adverse events | Atorvastatin 10 mg | 0 | 17 |
| Total, serious adverse events | Pravastatin 80 mg | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22264573 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atorvastatin 10 mg vs Pravastatin 80 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00166036
GET https://conductscience.org/api/trials/v1/NCT00166036/registered