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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02520206
Other study ID # SF11093
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 28, 2015
Last updated August 6, 2015
Start date January 2011
Est. completion date August 2015

Study information

Verified date August 2015
Source National Chung Hsing University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 250
Est. completion date August 2015
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
National Chung Hsing University Ministry of Science and Technology, Taiwan, National Science Council, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary s-adenosylmethionine 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 No
Primary homocysteine 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 No
Primary folate 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 No
Primary vitamin B6 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 No
Secondary blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine) 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 No
Secondary gene expression of target enzymes in PBMCs 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 No
Secondary enzyme activities of S-adenosylmethionine synthase in RBC 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 No
Secondary vitamin B6 metabolic enzyme in RBC 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 No
Secondary polymorphisms in one carbon metabolism enzymes in PBMCs 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 No
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