Adenosylmethionine Metabolism in Human Inflammation
Primary Purpose
Arthritis, Chronic Inflammation
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Arthritis
Health control subjects
Arm Description
subjects with arthritis
Health control
Outcomes
Primary Outcome Measures
s-adenosylmethionine
blood samples were collected and stored for later analyses of above metabolites
homocysteine
blood samples were collected and stored for later analyses of above metabolites
folate
blood samples were collected and stored for later analyses of above metabolites
vitamin B6
blood samples were collected and stored for later analyses of above metabolites
Secondary Outcome Measures
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
blood samples were collected and stored for later analyses of above metabolites
gene expression of target enzymes in PBMCs
blood samples were collected and stored for later analyses
enzyme activities of S-adenosylmethionine synthase in RBC
blood samples were collected and stored for later analyses of above metabolites
vitamin B6 metabolic enzyme in RBC
blood samples were collected and stored for later analyses of above metabolites
polymorphisms in one carbon metabolism enzymes in PBMCs
blood samples were collected and stored for later analyses
Full Information
NCT ID
NCT02520206
First Posted
July 28, 2015
Last Updated
August 6, 2015
Sponsor
National Chung Hsing University
Collaborators
National Science Council, Taiwan, Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02520206
Brief Title
Adenosylmethionine Metabolism in Human Inflammation
Official Title
Translational Study on the Regulation of Adenosylmethionine Synthesis During Chronic Inflammation
Study Type
Observational
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Chung Hsing University
Collaborators
National Science Council, Taiwan, Ministry of Science and Technology, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Chronic Inflammation
7. Study Design
Enrollment
250 (Anticipated)
Biospecimen Retention
Samples With DNA
Biospecimen Description
plasma, RBC, PBMC
8. Arms, Groups, and Interventions
Arm Title
Arthritis
Arm Description
subjects with arthritis
Arm Title
Health control subjects
Arm Description
Health control
Primary Outcome Measure Information:
Title
s-adenosylmethionine
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
Title
homocysteine
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
Title
folate
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
Title
vitamin B6
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
Secondary Outcome Measure Information:
Title
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
Title
gene expression of target enzymes in PBMCs
Description
blood samples were collected and stored for later analyses
Time Frame
Blood were collected at admission.Blood were dawn again 1mo later if his medication was changed by the doctor
Title
enzyme activities of S-adenosylmethionine synthase in RBC
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
Title
vitamin B6 metabolic enzyme in RBC
Description
blood samples were collected and stored for later analyses of above metabolites
Time Frame
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
Title
polymorphisms in one carbon metabolism enzymes in PBMCs
Description
blood samples were collected and stored for later analyses
Time Frame
Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Population Description
patients with arthritis or healthy adults
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Pei I Chiang, PhD
Organizational Affiliation
Department of Food Science and Biotechnology, National Chung Hsing University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Adenosylmethionine Metabolism in Human Inflammation
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