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Adenosylmethionine Metabolism in Human Inflammation

6 de agosto de 2015 atualizado 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.

Visão geral do estudo

Status

Desconhecido

Descrição detalhada

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 estudo

Observacional

Inscrição (Antecipado)

250

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

patients with arthritis or healthy adults

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Coortes e Intervenções

Grupo / Coorte
Arthritis
subjects with arthritis
Health control subjects
Health control

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
s-adenosylmethionine
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: En-Pei I Chiang, PhD, Department of Food Science and Biotechnology, National Chung Hsing University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2011

Conclusão Primária (Real)

1 de julho de 2014

Conclusão do estudo (Antecipado)

1 de agosto de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

28 de julho de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de agosto de 2015

Primeira postagem (Estimativa)

11 de agosto de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

11 de agosto de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2015

Última verificação

1 de agosto de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SF11093

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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