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Trial record 7 of 35 for:    Niemann Pick C

Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study (EZEmRNA)

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ClinicalTrials.gov Identifier: NCT01849068
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Patrick Couture, Laval University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Metabolic Syndrome X
Interventions Drug: Ezetimibe
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ezetimibe First, Then Placebo Placebo First, Then Ezetimibe
Hide Arm/Group Description First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Ezetimibe First Then Placebo Placebo First Then Ezetimibe Total
Hide Arm/Group Description First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
39.4  (7.9) 39.4  (13.6) 39.4  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions
Hide Description

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).

Time Frame At the end of the two 12-week interventions (Week 12 and 24)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description:
Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
Placebo: Placebo for 12 weeks Placebo for 12 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: #copies/100000 copies housekeeping gene
110531  (32604) 95140  (31840)
2.Secondary Outcome
Title Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
Hide Description

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).

Time Frame At the end of the two 12-week interventions (Week 12 and 24)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description:
Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
Placebo: Placebo for 12 weeks Placebo for 12 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: #copies/100000 copies housekeeping gene
HMGCoA reductase 354911  (102607) 311268  (88237)
PCSK9 9079  (5816) 8091  (6131)
SREBP-2 193012  (32787) 182349  (36681)
NPC1L1 454298  (97707) 448686  (138746)
ABCG5 271811  (111688) 283863  (132434)
ABCG8 125315  (46842) 129551  (63246)
3.Secondary Outcome
Title Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions
Hide Description

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).

Time Frame At the end of the two 12-week interventions (Week 12 and 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Data will never be analyzed because the mRNA expression of LDL receptor is sufficient.
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description:
Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
Placebo: Placebo for 12 weeks Placebo for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
Hide Description

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).

Time Frame At the end of the two 12-week interventions (Week 12 and 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient.
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description:
Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
Placebo: Placebo for 12 weeks Placebo for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks Placebo for 12 weeks Placebo for 12 weeks
All-Cause Mortality
Ezetimibe Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ezetimibe Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ezetimibe Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Patrick Couture MD, PhD, FRCP
Organization: Laval University
Phone: 418-654-2106
EMail: patrick.couture@crchul.ulaval.ca
Layout table for additonal information
Responsible Party: Patrick Couture, Laval University
ClinicalTrials.gov Identifier: NCT01849068     History of Changes
Other Study ID Numbers: INAF-B13-04-1195
First Submitted: May 6, 2013
First Posted: May 8, 2013
Results First Submitted: February 15, 2016
Results First Posted: April 12, 2016
Last Update Posted: April 12, 2016