Methylation Biosignature in Childhood Chronic Kidney Disease (childhoodCKD)
Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease
Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.
In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.
The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Kaohsiung, Taiwán, 833
- Kaohsiung Chang Gung Memorial Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- chronic kidney disease stage 1-4
- Volunteer
Exclusion Criteria:
- pregnancy
- renal transplant
- congenital heart disease
- not able to be adherent/complaint with study procedure
- not volunteer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
2/study, control
Study group: children aged<18 years with chronic kidney disease Control group: children aged<18 years without chronic kidney disease Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
|
Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
Periodo de tiempo: from the time of enrollment, every 6 months, up to 24 months
|
at the time of enrollment, 6 months, 12 months, 18 months, and 24 months
|
from the time of enrollment, every 6 months, up to 24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
change from the baseline health-related quality of life at 24 months
Periodo de tiempo: from the time of enrollment, every 6 months, up to 24 months
|
EQ-5D-Y instrument will be employed at the time of enrollment, 6 months, 12 months, 18 months, 24 months
|
from the time of enrollment, every 6 months, up to 24 months
|
|
change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 months
Periodo de tiempo: from the time of enrollment, every 6 months, up to 24 months
|
at the time of enrollment, 6 months, 12 months, 18 months, 24 months
|
from the time of enrollment, every 6 months, up to 24 months
|
|
change from the baseline level of hyperhomocysteinemia (Hcy) at 24 months
Periodo de tiempo: from the time of enrollment, every 6 months, up to 24 months
|
at the time of enrollment, 6 months, 12 months, 18 months, 24 months
|
from the time of enrollment, every 6 months, up to 24 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: You-Lin Tain, MD, PhD, Chang Gung Memorial Hospital
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 (Actual)
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
- 102-4131C
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. .