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This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.
We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acipimox | Active Comparator | Acipimox treatment QID for 7 days |
|
| Placebo | Placebo Comparator | Placebo treatment QID for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acipimox | Drug | 250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Vasodilation | Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period | After 7 days of each treatment. |
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Inclusion Criteria:
Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:
Normal cardiovascular examination
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua A. Beckman, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31571412 | Result | Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 2019 Oct 1. | |
| 39888728 | Derived | Sullivan AE, Courvan MCS, Ada AW, Wasserman DH, Niswender KD, Shardelow EM, Wells EK, Wells QS, Freiberg MS, Beckman JA. The Role of Serum Free Fatty Acids in Endothelium-Dependent Microvascular Function. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70031. doi: 10.1002/edm2.70031. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period |
| |||||||||||||
| Crossover |
|
This is a crossover trial in non diabetic subjects with and without the metabolic syndrome.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acipimox First | 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 |
| BG001 | Placebo First |
| 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 | Flow Mediated Vasodilation | Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period | Posted | Mean | Standard Deviation | percentage of vasodilation | After 7 days of each treatment. |
|
|
3 months
It does not differ
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Beckman | UT Southwestern | 214-648-3100 | joshua.beckman@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 28, 2008 | Dec 25, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C027696 | acipimox |
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| Placebo | Drug | 1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit |
|
| NOT COMPLETED |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
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| D009750 |
| Nutritional and Metabolic Diseases |