Spinal Cord Injury Clinical Trial
Official title:
Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
The overall study objectives are to examine whether:
1. 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
2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks
associated with fasting and postprandial lipidemia, glycemia, and vascular
inflammation.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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