Trial · NCT01849068
Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study
NCT01849068, Phase 3, Completed, Laval University; results first posted 2016-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study. Trials, record NCT01849068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01849068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study
- NCT number
- NCT01849068
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Laval University
- Conditions
- Metabolic Syndrome X
- Interventions
- Ezetimibe, Placebo
- First posted
- 2013-05-08
- Last updated
- 2016-04-12
- Results first posted
- 2016-04-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation). We combined the results at the end of each placebo phase from both sequence (average and standard deviation). |
| Secondary | Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation). We combined the results at the end of each placebo phase from both sequence (average and standard deviation). |
| Secondary | Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation). We combined the results at the end of each placebo phase from both sequence (average and standard deviation). |
| Secondary | Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation). We combined the results at the end of each placebo phase from both sequence (average and standard deviation). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | #copies/100000 copies housekeeping gene | MEAN | |
| SECONDARY | Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | #copies/100000 copies housekeeping gene | MEAN | |
| SECONDARY | Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | Data will never be analyzed because the mRNA expression of LDL receptor is sufficient. | ||
| SECONDARY | Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | At the end of the two 12-week interventions (Week 12 and 24) | Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions | Ezetimibe | 110531 | Standard Deviation 32604 | #copies/100000 copies housekeeping gene | |
| Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions | Placebo | 95140 | Standard Deviation 31840 | #copies/100000 copies housekeeping gene | |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Ezetimibe | HMGCoA reductase | 354911 | Standard Deviation 102607 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Placebo | HMGCoA reductase | 311268 | Standard Deviation 88237 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Ezetimibe | PCSK9 | 9079 | Standard Deviation 5816 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Placebo | PCSK9 | 8091 | Standard Deviation 6131 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Ezetimibe | SREBP-2 | 193012 | Standard Deviation 32787 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Placebo | SREBP-2 | 182349 | Standard Deviation 36681 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Ezetimibe | NPC1L1 | 454298 | Standard Deviation 97707 | #copies/100000 copies housekeeping gene |
| Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions | Placebo | NPC1L1 | 448686 | Standard Deviation 138746 | #copies/100000 copies housekeeping gene |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe First, Then Placebo | 10 | |
| Overall Study | STARTED | Placebo First, Then Ezetimibe | 10 | |
| Overall Study | COMPLETED | Ezetimibe First, Then Placebo | 10 | |
| Overall Study | COMPLETED | Placebo First, Then Ezetimibe | 10 | |
| Overall Study | NOT COMPLETED | Ezetimibe First, Then Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo First, Then Ezetimibe | 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 | Ezetimibe | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ezetimibe | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Ezetimibe | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Ezetimibe vs Placebo: 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/NCT01849068
GET https://conductscience.org/api/trials/v1/NCT01849068/registered