Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)

University of Miami

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.; Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days

Study type: Interventional

Funder types: Other

Identifiers

NCT01201759

20090361

TMP-MN-004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

18 participants in 2 patient groups

Placebo to Salsalate 2gr BID

Experimental group

Description:

Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.

Treatment:

Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days

Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.

Salsalate 2gr BID to placebo

Experimental group

Description:

Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.

Treatment:

Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days

Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.