Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- The Miami Project to Cure Paralysis
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Placebo to Salsalate 2gr BID
Placebo twice a day for 30 days.
Then Salsalate 2gr BID for 30 days.
|
Participants 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.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2
Participants 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.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2.
|
|
Experimental: Salsalate 2gr BID to placebo
Salsalate 2grams twice a day for 30 days.
Then Placebo for 30 days.
|
Participants 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.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2
Participants 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.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Periodo de tiempo: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min. For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Periodo de tiempo: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min. For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
|
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.
Periodo de tiempo: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min. For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
|
Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
Periodo de tiempo: Study visit at min -30 (fasting)
|
The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting). For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject's factors. |
Study visit at min -30 (fasting)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Inflamación
- Lesiones de la médula espinal
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Inhibidores de la ciclooxigenasa
- Ácido salicilsalicílico
- Salicilato de sodio
Otros números de identificación del estudio
- 20090361
- TMP-MN-004 (Otro identificador: Clinicaltrials.gov)
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