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Adenosylmethionine Metabolism in Human Inflammation

Primary Purpose

Arthritis, Chronic Inflammation

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Chung Hsing University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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