Adenosylmethionine Metabolism in Human Inflammation
6 de agosto de 2015 actualizado por: En-Pei Isabel Chiang, National Chung Hsing University
Translational Study on the Regulation of Adenosylmethionine Synthesis During Chronic Inflammation
The investigators propose to conduct a translational study on the regulation of S-adenosylmethionine synthesis and cellular methylation reactions during chronic inflammation.
Development of in vitro cell models may reveal the regulatory mechanisms by which specific inflammatory mediators cause metabolic changes and alter DNA methylation status.
Metabolic and pharmacological studies in the in vivo models will enable us to better understand the regulation of inter-organ homeostasis of S-adenosyl methionine and help identify tissue specific biomarkers for methylation and epigenetic modifications in different stage of chronic inflammation.
The clinical study in human subjects will help distinguish the impacts of autoimmune rheumatic disease, degenerated joint disease, or specific medication use on significant clinical and biochemical markers in folate and vitamin B6 metabolic pathways.The Investigators hope the present study can identify specific clinical markers for potential epigenetic changes in patients suffering from chronic inflammation, which will contribute to better clinical management of these diseases in humans.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
The significance of epigenetic alterations in autoimmune rheumatic diseases and degenerated joint diseases has drawn great attention among clinicians and researchers.
Aberrant methylation status has been demonstrated in human chronic inflammation yet more efforts have focused on global and sequence-specific hypomethylation and overexpression of specific genes.
Few studies investigated the regulation of S-adenosylmethionine homeostasis and regulation during inflammation.
At present the relevance and regulation of the complex epigenetic profiles and their modifications among different tissues and organs during inflammation remain largely unknown.
Tipo de estudio
De observación
Inscripción (Anticipado)
250
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
patients with arthritis or healthy adults
Descripción
Inclusion Criteria:
- > 18 years
Exclusion Criteria:
- pregnancy,
- anemia (hemoglobin 10 mg/dL or lower),
- thrombocytopenia (platelet count below 50,000 cells/μL),
- abnormal serum hepatic transaminase (aspartate aminotransferase or alanine aminotransferase above 50 IU/L),
- diabetes or cancer
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Arthritis
subjects with arthritis
|
|
Health control subjects
Health control
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
s-adenosylmethionine
Periodo de tiempo: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
|
homocysteine
Periodo de tiempo: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
|
folate
Periodo de tiempo: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
|
vitamin B6
Periodo de tiempo: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
Periodo de tiempo: Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
|
gene expression of target enzymes in PBMCs
Periodo de tiempo: Blood were collected at admission.Blood were dawn again 1mo later if his medication was changed by the doctor
|
blood samples were collected and stored for later analyses
|
Blood were collected at admission.Blood were dawn again 1mo later if his medication was changed by the doctor
|
|
enzyme activities of S-adenosylmethionine synthase in RBC
Periodo de tiempo: Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
|
vitamin B6 metabolic enzyme in RBC
Periodo de tiempo: Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
blood samples were collected and stored for later analyses of above metabolites
|
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
|
polymorphisms in one carbon metabolism enzymes in PBMCs
Periodo de tiempo: Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
blood samples were collected and stored for later analyses
|
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: En-Pei I Chiang, PhD, Department of Food Science and Biotechnology, National Chung Hsing University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2011
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Anticipado)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
28 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2015
Publicado por primera vez (Estimar)
11 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de agosto de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2015
Última verificación
1 de agosto de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SF11093
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. .