- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02520206
Adenosylmethionine Metabolism in Human Inflammation
6. august 2015 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
250
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
patients with arthritis or healthy adults
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Arthritis
subjects with arthritis
|
Health control subjects
Health control
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
s-adenosylmethionine
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: En-Pei I Chiang, PhD, Department of Food Science and Biotechnology, National Chung Hsing University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. juli 2014
Studiet fullført (Forventet)
1. august 2015
Datoer for studieregistrering
Først innsendt
28. juli 2015
Først innsendt som oppfylte QC-kriteriene
6. august 2015
Først lagt ut (Anslag)
11. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SF11093
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