Trial Outcomes & Findings for The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome (NCT NCT00759291)
NCT ID: NCT00759291
Last Updated: 2023-02-21
Results Overview
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
After 7 days of each treatment.
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Acipimox First, Then Placebo
Acipimox treatment QID for 7 days, followed by a 4 week washout, and then Placebo treatment QID for 7 days.
Acipimox: 250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit.
Placebo: 250 mg placebo tablets orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit.
|
Placebo First, Then Acipimox
Placebo treatment QID for 7 days, followed by a four week washout, and then acipimox treatment for 7 day.
Placebo: 250 mg placebo tablets orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit.
Four week washout.
Acipimox treatment QID for 7 days, followed by a 4 week washout, and then Placebo treatment QID for 7 days.
|
|---|---|---|
|
First Treatment Period
STARTED
|
17
|
23
|
|
First Treatment Period
COMPLETED
|
17
|
23
|
|
First Treatment Period
NOT COMPLETED
|
0
|
0
|
|
Crossover
STARTED
|
17
|
23
|
|
Crossover
COMPLETED
|
17
|
23
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Acipimox First
n=17 Participants
Acipimox treatment QID for 7 days
Acipimox: 250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
then
Placebo: 1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
|
Placebo First
n=23 Participants
Placebo treatment QID for 7 days
Placebo: 1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
then
Acipimox: 250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 6 • n=93 Participants
|
60 years
STANDARD_DEVIATION 11 • n=4 Participants
|
56 years
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: After 7 days of each treatment.Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
Outcome measures
| Measure |
Metabolic Syndrome
n=18 Participants
Subjects with 3 or more criteria for metabolic syndrome.
|
Control
n=17 Participants
Subjects without metabolic syndrome
|
|---|---|---|
|
Flow Mediated Vasodilation
Placebo
|
9.5 percentage of vasodilation
Standard Deviation 6.5
|
10.8 percentage of vasodilation
Standard Deviation 4.9
|
|
Flow Mediated Vasodilation
Acipimox
|
10.5 percentage of vasodilation
Standard Deviation 6
|
10.9 percentage of vasodilation
Standard Deviation 6.2
|
Adverse Events
Acipimox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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