ArthritisNCT02520206
Adenosylmethionine Metabolism in Human Inflammation
An observational study of Arthritis and Chronic Inflammation, run by National Chung Hsing University.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Chronic Inflammation
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with arthritis or healthy adults
Who may be able to join
- > 18 years
Who cannot join
- 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
About this study
Official title: Translational Study on the Regulation of Adenosylmethionine Synthesis During Chronic Inflammation
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.
Read the 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.
- Conditions
- Arthritis, Chronic Inflammation
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arthritis | subjects with arthritis | |
| Health control subjects | Health control |
What is being measured
The primary outcome is the main question the study is designed to answer.
s-adenosylmethionine
blood samples were collected and stored for later analyses of above metabolites
Measured: 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
Measured: 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
Measured: 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
Measured: 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 samples were collected and stored for later analyses of above metabolites
Measured: 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 samples were collected and stored for later analyses
Measured: 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 samples were collected and stored for later analyses of above metabolites
Measured: 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 samples were collected and stored for later analyses of above metabolites
Measured: 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 samples were collected and stored for later analyses
Measured: Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Chung Hsing University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, En-Pei Isabel Chiang, National Chung Hsing University
- Investigators
- En-Pei I Chiang, PhD, Principal investigator, Department of Food Science and Biotechnology, National Chung Hsing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520206
- Sponsor's protocol ID
- SF11093
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study on the Regulation of Adenosylmethionine Synthesis During Chronic Inflammation
- ClinicalTrials.gov ID
- NCT02520206
- Acronym / sponsor ID
- SF11093
- Conditions
- Arthritis, Chronic Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Chung Hsing UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Ministry of Science and Technology, Taiwan
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthritis | – | –subjects with arthritis |
| Health control subjects | – | –Health control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with arthritis or healthy adults
Key inclusion criteria (1 listed)
- > 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
s-adenosylmethionine
Time frame: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
blood samples were collected and stored for later analyses of above metabolites
homocysteine
Time frame: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
blood samples were collected and stored for later analyses of above metabolites
folate
Time frame: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
blood samples were collected and stored for later analyses of above metabolites
vitamin B6
Time frame: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor
blood samples were collected and stored for later analyses of above metabolites
5 secondary outcomes
blood amino acid profile (serine, glycine, methionine,cysteine, cystathionine, dimethylglycine)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Blood were collected at admission. Blood were dawn again 1mo later if his medication was changed by the doctor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
En-Pei I Chiang, PhD principal investigator
Department of Food Science and Biotechnology, National Chung Hsing University
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Chronic Inflammation, run by National Chung Hsing University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
s-adenosylmethionine (time frame: Blood were collected at admission. Some participants were followed for 4wks if medication was changed by the doctor). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.