Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke and developing cognitive functioning problems than people without diabetes who undergo heart surgery. There may be a connection between disturbances in glucose metabolism, endothelial dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who receive more intensive blood glucose management during and after heart surgery may have better neurological outcomes than people who control their blood glucose levels in a standard way. The purpose of this study is to evaluate the effectiveness of using a traditional method of controlling blood glucose levels versus a tailored, more intensive method of glucose control on neurological outcomes in people with diabetes who are undergoing heart surgery. Researchers will also examine genetic factors that may be associated with insulin resistance and inflammation.
This study will enroll people undergoing heart surgery. On the day before surgery, participants will undergo a blood collection and neuropsychological testing. They will then be randomly assigned to either a traditional method of blood glucose control or an intensive, tailored method of blood glucose control. Participants following the traditional method of blood glucose control may receive insulin several times a day, based on the results of glucose monitoring. Participants following the intensive, tailored method of blood glucose control will undergo hourly measurements of their glucose levels and receive insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery, all participants will undergo an ultrasound of their neck to monitor blood vessel activity. Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours after surgery, and upon hospital discharge or 5 days after surgery.
One week after surgery or just before leaving the hospital, participants will undergo a magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving the hospital, participants will take part in a diabetes education session and nutrition counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat neuropsychological testing. Once a month for 6 months, participants who received the intensive, tailored method of blood glucose control will attend study visits at which time study researchers will monitor their diabetes.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
North Carolina
-
Winston-Salem, North Carolina, Estados Unidos, 27057
- Wake Forest Baptist Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission
- Scheduled to undergo coronary artery bypass graft (CABG) surgery
- Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both
- Scheduled to undergo valve replacement with CABG
Exclusion Criteria:
- Undergoing emergent (i.e., urgent) procedures
- Alzheimer's disease or similar dementias
- Severe claustrophobia
- Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL
- Cannot be expected to complete neuropsychological testing
- Recent extensive, life threatening acute myocardial infarction (AMI)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intensive Glucose Management
Participants will receive intensive glucose management.
|
Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU).
Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL.
Prior to hospital discharge, participants will receive an in-depth diabetes education session.
After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.
|
|
Comparador activo: Traditional Glucose Management
Participants will receive a traditional method of glucose management.
|
Participants will receive traditional management of blood glucose levels while in the hospital.
They may receive insulin several times a day, based on the results of glucose monitoring.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
Periodo de tiempo: Measured 1 week after surgery
|
Measured 1 week after surgery
|
|
Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)
Periodo de tiempo: Measured 6 months after surgery
|
Measured 6 months after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of lesions, as measured by MRI
Periodo de tiempo: Measured 1 week after surgery
|
Measured 1 week after surgery
|
|
Size of lesions, as measured by MRI
Periodo de tiempo: Measured 1 week after surgery
|
Measured 1 week after surgery
|
|
Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)
Periodo de tiempo: Measured 6 months after surgery
|
Measured 6 months after surgery
|
|
Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)
Periodo de tiempo: Measured 6 months after surgery
|
Measured 6 months after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Edward H. Kincaid, MD, Wake Forest University Health Sciences
- Director de estudio: Jorge Calles-Escandon, MD, Wake Forest University Health Sciences
- Director de estudio: Donald W. Bowden, PhD, Wake Forest University Health Sciences
- Director de estudio: David A. Stump, PhD, Wake Forest University Health Sciences
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
Otros números de identificación del estudio
- 615
- R01HL089115-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .