Trial Outcomes & Findings for To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects (NCT NCT01420328)
NCT ID: NCT01420328
Last Updated: 2024-04-17
Results Overview
Percent change from baseline (0 week) in cream challenge induced change in CD68 mRNA expression in MNC after 6 weeks of treatment with Vytorin or placebo. Outcome calculated as: (change at 6 weeks- change at 0 week)/ change at 0 week\*100
COMPLETED
NA
20 participants
0 weeks and 6 weeks
2024-04-17
Participant Flow
Participant milestones
| Measure |
Placebo Arm
Placebo tablets given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
Vytorin Arm
Vytorin: Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin) given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
|---|---|---|
|
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
To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects
Baseline characteristics by cohort
| Measure |
Placebo Arm/Description
n=10 Participants
10 subjects with obesity but not diabetes and LDL \>100 mg/dl on placebo treatment for 6 weeks
|
Vytorin Arm/Description
n=10 Participants
10 subjects with obesity but not diabetes and LDL \>100 mg/dl on Vytorin for 6 weeks
Vytorin: Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 4 • n=99 Participants
|
51 years
STANDARD_DEVIATION 3 • n=107 Participants
|
50 years
STANDARD_DEVIATION 3.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
BMI
|
38.1 Kg/m^2
STANDARD_DEVIATION 1.6 • n=99 Participants
|
38.2 Kg/m^2
STANDARD_DEVIATION 1.7 • n=107 Participants
|
38.2 Kg/m^2
STANDARD_DEVIATION 1.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 0 weeks and 6 weeksPopulation: All patients entered into study were analyzed
Percent change from baseline (0 week) in cream challenge induced change in CD68 mRNA expression in MNC after 6 weeks of treatment with Vytorin or placebo. Outcome calculated as: (change at 6 weeks- change at 0 week)/ change at 0 week\*100
Outcome measures
| Measure |
Placebo Arm
n=10 Participants
Placebo tablets given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
Vytorin Arm
n=10 Participants
Vytorin: Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin) given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
|---|---|---|
|
Change in CD68 mRNA Expression in MNC
|
10 percentage of change
Standard Error 9
|
-68 percentage of change
Standard Error 13
|
SECONDARY outcome
Timeframe: 6 weeksPercent change from baseline (0 week) in cream -induced change in CD16 mRNA expression in MNC after 6 weeks of treatment with Vytorin or placebo. Outcome calculated as: (change at 6 weeks- change at 0 week)/ change at 0 week\*100
Outcome measures
| Measure |
Placebo Arm
n=10 Participants
Placebo tablets given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
Vytorin Arm
n=10 Participants
Vytorin: Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin) given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
|---|---|---|
|
Change in Cream-induced Expression of CD16
|
-10 percentage of change
Standard Error 12
|
-57 percentage of change
Standard Error 13
|
SECONDARY outcome
Timeframe: 6 weeksPercent change from baseline (0 week) in cream -induced change in IL-1b mRNA expression in MNC after 6 weeks of treatment with Vytorin or placebo. Outcome calculated as: (change at 6 weeks- change at 0 week)/ change at 0 week\*100
Outcome measures
| Measure |
Placebo Arm
n=10 Participants
Placebo tablets given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
Vytorin Arm
n=10 Participants
Vytorin: Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin) given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
|---|---|---|
|
Change IL-1b mRNA Expression
|
-13 percentage of change
Standard Error 8
|
-74 percentage of change
Standard Error 15
|
SECONDARY outcome
Timeframe: 6 weekschange from baseline (0 week) in cream -induced change in plasma endotoxin concentration after 6 weeks of treatment with Vytorin or placebo. Outcome calculated as: (change at 6 weeks- change at 0 week)
Outcome measures
| Measure |
Placebo Arm
n=10 Participants
Placebo tablets given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
Vytorin Arm
n=10 Participants
Vytorin: Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin) given to 10 subjects with obesity but not diabetes and LDL \>100 mg/dl on no lipid lowering therapy for a 6 weeks period
|
|---|---|---|
|
Change in Plasma Endotoxin (LPS) Concentrations
|
0.11 EU/ml
Standard Error 0.09
|
-0.23 EU/ml
Standard Error 0.08
|
Adverse Events
Placebo Arm
Vytorin Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Husam Ghanim
Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place