Adenosylmethionine Metabolism in Human Inflammation

NCT02520206 | Unknown DMC

• 1 other identifier: SF11093
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Arthritis; Chronic Inflammation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (5)

• blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)

  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

  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

  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

  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

  Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor

Study Arms (2)

Arthritis

subjects with arthritis

Health control subjects

Health control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with arthritis or healthy adults

You may qualify if:

• \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• National Chung Hsing University: lead
• National Science and Technology Council, Taiwan: collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

plasma, RBC, PBMC

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• En-Pei I Chiang, PhD

  Department of Food Science and Biotechnology, National Chung Hsing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 11, 2015
• Study Start: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08