Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
The overall study objectives are to examine whether:
- Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
- An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.
研究概览
地位
条件
详细说明
To test Study Objective 1, 'overweight' and 'non-overweight' persons with SCI will be compared at baseline for fasting and postprandial responses. For Study Objective 2, all persons tested for Study Objective 1 will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. The last month will test effects of drug-placebo not examined in month 2. Fasting and postprandial responses will be tested at each time point. Intention-to-treat clinical standards ("…as randomized, so analyzed…") and 'last observation carried forward' clinical methods will be adopted.
Participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in CVD, CVD risks, and obesity.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Florida
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Miami、Florida、美国、33136
- The Miami Project to Cure Paralysis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- SCI resulting in tetraplegia at C3-C7
- injury for more than one year
Exclusion Criteria:
- 1. any recent dietary or other lifestyle changes;
- 2. diabetes or inflammatory medical conditions;
- 3. a pressure ulcer;
- 4. lung or bladder infection;
- 5. undiagnosed illness or fever;
- 6. recent surgery;
- 7. stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or ,
- 8. currently taking medicines used for pain or inflammation (aspirin and non-steroidal anti-inflammatory drugs, corticosteroids), blood vessel diseases (statins or fibric acid derivatives), blood clotting disorders (Coumadin, Plavix), infections (antibiotics), diabetes (Metformin), and burning 'central' pain (voltage regulators).
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Placebo to Salsalate 2gr BID
Placebo twice a day for 30 days.
Then Salsalate 2gr BID for 30 days.
|
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2.
|
|
实验性的：Salsalate 2gr BID to placebo
Salsalate 2grams twice a day for 30 days.
Then Placebo for 30 days.
|
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
大体时间：Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min. For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
大体时间：Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min. For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
大体时间：Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min. For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
大体时间：Study visit at min -30 (fasting)
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The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting). For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject's factors. |
Study visit at min -30 (fasting)
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合作者和调查者
调查人员
- 首席研究员：Mark S Nash, PhD、University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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