- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02520206
Adenosylmethionine Metabolism in Human Inflammation
6. august 2015 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
250
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Kohorter og interventioner
Gruppe / kohorte |
---|
Arthritis
subjects with arthritis
|
Health control subjects
Health control
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: En-Pei I Chiang, PhD, Department of Food Science and Biotechnology, National Chung Hsing University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
1. juli 2014
Studieafslutning (Forventet)
1. august 2015
Datoer for studieregistrering
Først indsendt
28. juli 2015
Først indsendt, der opfyldte QC-kriterier
6. august 2015
Først opslået (Skøn)
11. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SF11093
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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