- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02520206
Adenosylmethionine Metabolism in Human Inflammation
6 sierpnia 2015 zaktualizowane przez: 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.
Przegląd badań
Status
Nieznany
Warunki
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Oczekiwany)
250
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
patients with arthritis or healthy adults
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Arthritis
subjects with arthritis
|
|
Health control subjects
Health control
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
s-adenosylmethionine
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: En-Pei I Chiang, PhD, Department of Food Science and Biotechnology, National Chung Hsing University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2011
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2014
Ukończenie studiów (Oczekiwany)
1 sierpnia 2015
Daty rejestracji na studia
Pierwszy przesłany
28 lipca 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 sierpnia 2015
Pierwszy wysłany (Oszacować)
11 sierpnia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
11 sierpnia 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 sierpnia 2015
Ostatnia weryfikacja
1 sierpnia 2015
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SF11093
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .