Trial Outcomes & Findings for Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study (NCT NCT01849068)
NCT ID: NCT01849068
Last Updated: 2016-04-12
Results Overview
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).
COMPLETED
PHASE3
20 participants
At the end of the two 12-week interventions (Week 12 and 24)
2016-04-12
Participant Flow
Participant milestones
| Measure |
Ezetimibe First, Then Placebo
First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks
|
Placebo First, Then Ezetimibe
First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study
Baseline characteristics by cohort
| Measure |
Ezetimibe First Then Placebo
n=10 Participants
First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks
|
Placebo First Then Ezetimibe
n=10 Participants
First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Ezetimibe
n=20 Participants
Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
|
Placebo
n=20 Participants
Placebo: Placebo for 12 weeks Placebo for 12 weeks
|
|---|---|---|
|
Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions
|
110531 #copies/100000 copies housekeeping gene
Standard Deviation 32604
|
95140 #copies/100000 copies housekeeping gene
Standard Deviation 31840
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Ezetimibe
n=20 Participants
Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
|
Placebo
n=20 Participants
Placebo: Placebo for 12 weeks Placebo for 12 weeks
|
|---|---|---|
|
Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
HMGCoA reductase
|
354911 #copies/100000 copies housekeeping gene
Standard Deviation 102607
|
311268 #copies/100000 copies housekeeping gene
Standard Deviation 88237
|
|
Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
PCSK9
|
9079 #copies/100000 copies housekeeping gene
Standard Deviation 5816
|
8091 #copies/100000 copies housekeeping gene
Standard Deviation 6131
|
|
Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
SREBP-2
|
193012 #copies/100000 copies housekeeping gene
Standard Deviation 32787
|
182349 #copies/100000 copies housekeeping gene
Standard Deviation 36681
|
|
Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
NPC1L1
|
454298 #copies/100000 copies housekeeping gene
Standard Deviation 97707
|
448686 #copies/100000 copies housekeeping gene
Standard Deviation 138746
|
|
Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
ABCG5
|
271811 #copies/100000 copies housekeeping gene
Standard Deviation 111688
|
283863 #copies/100000 copies housekeeping gene
Standard Deviation 132434
|
|
Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions
ABCG8
|
125315 #copies/100000 copies housekeeping gene
Standard Deviation 46842
|
129551 #copies/100000 copies housekeeping gene
Standard Deviation 63246
|
SECONDARY outcome
Timeframe: At the end of the two 12-week interventions (Week 12 and 24)Population: Data will never be analyzed because the mRNA expression of LDL receptor is sufficient.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of the two 12-week interventions (Week 12 and 24)Population: Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient.
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).
Outcome measures
Outcome data not reported
Adverse Events
Ezetimibe
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place