Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI|
- Area Under the Curve (AUC)for lipemia [ Time Frame: 5 visits over 4 months ] [ Designated as safety issue: No ]The postprandial lipemia is assessed by the AUC for triglycerides.
- Area Under the Curve (AUC) for glycemia [ Time Frame: 5 visits over 4 months ] [ Designated as safety issue: No ]The post-prandial glycemia is assessed by the AUC for glucose and insulin.
- Area Under the Curve (AUC)for vascular inflammation [ Time Frame: 5 visits over 4 months ] [ Designated as safety issue: No ]The pro-atherogenic inflammatory mediators are AUCs for post-prandial C-reactive protein and Interleukin-6.
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201759
|Contact: Kimberly D Anderson, PhDfirstname.lastname@example.org|
|United States, Florida|
|The Miami Project to Cure Paralysis||Recruiting|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Mark S Nash, PhD||University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis|