Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI resulting in tetraplegia at C3-C7
- •injury for more than one year
排除标准
- •any recent dietary or other lifestyle changes;
- •diabetes or inflammatory medical conditions;
- •a pressure ulcer;
- •lung or bladder infection;
- •undiagnosed illness or fever;
- •recent surgery;
- •stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or ,
- •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).
研究组 & 干预措施
Placebo to Salsalate 2gr BID
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
干预措施: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days (Drug)
Placebo to Salsalate 2gr BID
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
干预措施: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. (Drug)
Salsalate 2gr BID to placebo
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.
干预措施: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days (Drug)
Salsalate 2gr BID to placebo
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.
干预措施: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. (Drug)
结局指标
主要结局
Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
时间窗: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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.
次要结局
- Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.(Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..)
- 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.(Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..)
- Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5(Study visit at min -30 (fasting))
研究者
Mark S. Nash, Ph.D., FACSM
Professor
University of Miami