Adenosylmethionine Metabolism in Human Inflammation

Arthritis Clinical Trial

Official title:

Translational Study on the Regulation of Adenosylmethionine Synthesis During Chronic Inflammation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02520206
• Other study ID #: SF11093
• 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

• Arthritis
• Chronic Inflammation
• Inflammation

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