N/A
Completed N=18
Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Source: ClinicalTrials.gov NCT01201759 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment. — -34; -62 mg*min/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment. |
-34; -62 | — |
| SECONDARY Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment. |
1; -8 | — |
| SECONDARY 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. |
8; -111 | — |
| SECONDARY Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5 |
0.48; 0.51; 0.50; 0.19 | — |
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).
Data sourced from ClinicalTrials.gov (NCT01201759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.