Trial Outcomes & Findings for The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes (NCT NCT01980524)
NCT ID: NCT01980524
Last Updated: 2017-04-04
Results Overview
Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
8 participants
Primary outcome timeframe
180 minutes
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
Acipimox First
Participants received acipimox 250 mg at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a placebo capsule at 0 and 180 minutes
|
Placebo
Participants received a placebo capsule at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a acipimox 250 mg at 0 and 180 minutes
|
|---|---|---|
|
Study Day 1
STARTED
|
4
|
4
|
|
Study Day 1
COMPLETED
|
4
|
4
|
|
Study Day 1
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 2 Weeks)
STARTED
|
4
|
4
|
|
Washout (at Least 2 Weeks)
COMPLETED
|
4
|
4
|
|
Washout (at Least 2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Study Day 2
STARTED
|
4
|
4
|
|
Study Day 2
COMPLETED
|
4
|
4
|
|
Study Day 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
All Study Participants
n=8 Participants
On study day 1 subjects received acipimox 250 mg or placebo at 0 and 180 minutes (randomized, controlled, single blinded); after a wash out period of at least two weeks on study day 2 i) subjects who received acipimox 250 mg on study day 1 were administered placebo at 0 and 180 minutes and ii) subjects who received placebo on study day 1 were administered acipimox 250 mg at 0 and 180 minutes (randomized, controlled, single blinded).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 180 minutesIntramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo
Outcome measures
| Measure |
Acipimox+
n=8 Participants
250 mg at 0 and 180 minutes (one day)
acipimox
|
Placebo
n=8 Participants
1 capsule at 0 and 180 minutes (one day)
placebo
|
|---|---|---|
|
MYCL
Baseline
|
0.54 percentage of water signal
Standard Deviation 0.1
|
0.44 percentage of water signal
Standard Deviation 0.1
|
|
MYCL
180 minutes after administration
|
0.35 percentage of water signal
Standard Deviation 0.2
|
0.36 percentage of water signal
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 180 minutesLeft ventricular ejection fraction before and after administration of acipimox or placebo
Outcome measures
| Measure |
Acipimox+
n=8 Participants
250 mg at 0 and 180 minutes (one day)
acipimox
|
Placebo
n=8 Participants
1 capsule at 0 and 180 minutes (one day)
placebo
|
|---|---|---|
|
Ejection Fraction
Baseline
|
76 percentage
Standard Deviation 6
|
78 percentage
Standard Deviation 8
|
|
Ejection Fraction
180 minutes after administration
|
69 percentage
Standard Deviation 9
|
77 percentage
Standard Deviation 7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180 minutesStroke volume before and after administration of acipimox or placebo
Outcome measures
| Measure |
Acipimox+
n=8 Participants
250 mg at 0 and 180 minutes (one day)
acipimox
|
Placebo
n=8 Participants
1 capsule at 0 and 180 minutes (one day)
placebo
|
|---|---|---|
|
Stroke Volume
baseline
|
38 ml/m2
Standard Deviation 10
|
36 ml/m2
Standard Deviation 6
|
|
Stroke Volume
180 minutes after administration
|
31 ml/m2
Standard Deviation 8
|
36 ml/m2
Standard Deviation 6
|
Adverse Events
Acipimox+
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acipimox-
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