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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002656-32 | EudraCT Number |
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There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation.
Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acipimox+ | Experimental | 250 mg at 0 and 180 minutes (one day) |
|
| Placebo | Placebo Comparator | 1 Tablet at 0 and 180 minutes (one day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acipimox | Drug |
| ||
| Placebo Oral Capsule |
| Measure | Description | Time Frame |
|---|---|---|
| MYCL | Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection Fraction | Left ventricular ejection fraction before and after administration of acipimox or placebo | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Volume | Stroke volume before and after administration of acipimox or placebo | 180 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Krebs, Prof.MD | Medical University of Vienna, Dept. of Internal Medicine III, Division of Endocrinology and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Day 1 |
| |||||||||||||
| Washout (at Least 2 Weeks) |
| |||||||||||||
| Study Day 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MYCL | Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo | Posted | Mean | Standard Deviation | percentage of water signal | 180 minutes |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acipimox+ | 250 mg at 0 and 180 minutes (one day) acipimox |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Wolf | Medical University of Vienna | 004314040043110 | peter.wolf@meduniwien.ac.at |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C027696 | acipimox |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Ejection Fraction | Left ventricular ejection fraction before and after administration of acipimox or placebo | Posted | Mean | Standard Deviation | percentage | 180 minutes |
|
|
|
| Other Pre-specified | Stroke Volume | Stroke volume before and after administration of acipimox or placebo | Posted | Mean | Standard Deviation | ml/m2 | 180 minutes |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Acipimox- | 1 Tablet at 0 and 180 minutes (one day) acipimox | 0 | 8 | 0 | 8 |
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| D004700 | Endocrine System Diseases |