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The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.
To test the hypothesis that inhibition of I [kappa] B kinase [beta] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salsalate first, then Placebo | Active Comparator | In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion. |
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| Placebo first, then Salsalate | Placebo Comparator | In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy in a double-blinded fashion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salsalate | Drug | 1.5 grams orally 3 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated, Endothelium-dependent Vasodilation | Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared. | Upon completion of 4 weeks of salsalate and placebo treatment |
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Inclusion Criteria:
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 |
|---|---|---|---|
| 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. | |
| 24390146 | Derived | Nohria A, Kinlay S, Buck JS, Redline W, Copeland-Halperin R, Kim S, Beckman JA. The effect of salsalate therapy on endothelial function in a broad range of subjects. J Am Heart Assoc. 2014 Jan 3;3(1):e000609. doi: 10.1161/JAHA.113.000609. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atherosclerosis/Metabolic Syndrome: Salsalate First, Then Plac | Subjects with either Metabolic Syndrome/Atherosclerosis received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks. |
| FG001 | Atherosclerosis/Metabolic Syndrome: Placebo First, Then Salsal | Subjects with either Metabolic Syndrome/Atherosclerosis received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks. |
| FG002 | Healthy Subjects: Salsalate First, Then Placebo | Healthy subjects received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks. |
| FG003 | Healthy Subjects: Placebo First, Then Salsalate | Healthy subjects received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atherosclerosis or Metabolic Syndrome | Participant flow is identical to that of NCT00762827 ("The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome"): The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this arm, individuals with either Metabolic Syndrome or Atherosclerosis received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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, Endothelium-dependent Vasodilation | Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared. | The ultrasound data for two subjects was inadequate for analysis. This determination was made prior to unblinding. The data for these two subjects were discarded, leaving 56 subjects for analysis. | Posted | Median | Inter-Quartile Range | percentage vasodilation | Upon completion of 4 weeks of salsalate and placebo treatment |
|
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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 | Salsalate | Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment | 6 participants had study drug dose reduced to 3 g/day due to tinnitus, which resolved after dose reduction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Beckman | Brigham and Women's Hospital | 617-732-6186 | jbeckman@partners.org |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C014182 | salicylsalicylic acid |
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| placebo | Drug | matching placebo |
|
| BG001 | Healthy | Participant flow is identical to that of NCT00762827 ("The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome"): The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this control arm, healthy individuals received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls. |
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|
| 0 |
| 58 |
| 0 |
| 58 |
| 6 |
| 58 |
| EG001 | Placebo | Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Placebo | 0 | 58 | 0 | 58 | 0 | 58 |
|
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