Clinical trial NCT01201759: Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Official title: Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: cardiovascular risk
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
timeFrame: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Secondary outcomes:
measure: Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
timeFrame: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
measure: 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.
timeFrame: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
measure: Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
timeFrame: Study visit at min -30 (fasting)
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References: