DNA Exome Sequencing TCM for Sjögren's Syndrome
Study Details
Study Description
Brief Summary
To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Objective: To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome
Method:
This study wants to establish the reference value of DNA gene variants of healthy control for comparing with the Sjögren's syndrome subjects. And the investigators want to use the DNA Exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 Sjögren's syndrome subjects and at least 10 healthy control subjects. Finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and heart rate variability (HRV) for this purpose.
Expected Results:
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To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
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To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
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To evaluate the proteomics for the Sjögren's syndrome and healthy control.
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To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
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To evaluate the association among the immunity-related gene expression, SSA, SSB and RF.
Keyword: Sjögren's syndrome, Immune regulation, Gene modulation, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, proteomics, oral microbiome
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sjögren's syndrome Sjögren's syndrome patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) primary or secondary SS; (2) aged between 20 and 75 years; (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG); (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; or (3) steroid pulse therapy within three months prior to the commencement of our study. |
Diagnostic Test: DNA Exome sequencing
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
Diagnostic Test: Oral microbiome
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
Diagnostic Test: Proteomics
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
Diagnostic Test: RNA sequencing
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
Diagnostic Test: Cytokine
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
Diagnostic Test: Traditional Chinese Medicine pattern
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
Diagnostic Test: Heart rate variability
Sjögren's syndrome patients and health subjects will take the heart rate variability.
Diagnostic Test: Schirmer's test
Sjögren's syndrome patients will take the Schirmer's test.
Diagnostic Test: Blood function test, liver function test, kidney function test, and immune function test
Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
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| Health subjects Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 41 and 63 years (which the age could match the SS patients enrolling in the SS-1 trial); (2) had no chronic inflammatory illness. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; (3) abnormal findings of immune, liver, kidney, or blood function evaluations; (4) total sleeping time insufficiency less than 6 hours before one day of enrollment; (5) ever took the conventional medicine or hormone within one month; (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month. |
Diagnostic Test: DNA Exome sequencing
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
Diagnostic Test: Oral microbiome
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
Diagnostic Test: Proteomics
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
Diagnostic Test: RNA sequencing
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
Diagnostic Test: Cytokine
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
Diagnostic Test: Traditional Chinese Medicine pattern
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
Diagnostic Test: Traditional Chinese Medicine tongue diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
Diagnostic Test: Traditional Chinese Medicine pulse diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
Diagnostic Test: Heart rate variability
Sjögren's syndrome patients and health subjects will take the heart rate variability.
Diagnostic Test: Blood function test, liver function test, kidney function test, and immune function test
Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
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Outcome Measures
Primary Outcome Measures
- Immunity-related gene expression [One year]
To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control. DNA exome combine the GATK (Genome Analysis Toolkit) is a tool for detecting the ratio of immunity-related gene expression.
- TCM pattern [One year]
To evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control. TCM pattern is a tool for detecting the constitution.
- TCM tongue diagnosis [One year]
To evaluate the difference of TCM tongue diagnosis between Sjögren's syndrome and healthy control. TCM tongue diagnosis is a tool for detecting tongue expression.
- TCM pulse diagnosis [One year]
To evaluate the difference of TCM pulse diagnosis between Sjögren's syndrome and healthy control. TCM pulse diagnosis is a tool for detecting pulse of radial artery.
- Heart rate variability (HRV) [One year]
To evaluate the difference of Heart rate variability (HRV) between Sjögren's syndrome and healthy control. HRV is a tool for detecting the ratio between High-frequency (HF) activity and low-frequency (LF) activity.
- Immunity-related proteomics expression [One year]
To evaluate the proteomics for the Sjögren's syndrome and healthy control. Proteomics is a tool for detecting the ratio of immunity-related proteomics expression.
- Immunity-related microbiome expression [One year]
To evaluate the oral microbiome for the Sjögren's syndrome and healthy control. Oral microbiome is a tool for detecting the ratio of immunity-related microbiome expression.
Eligibility Criteria
Criteria
Sjögren's syndrome
Inclusion Criteria:
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(1) primary or secondary SS
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(2) aged between 20 and 75 years
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(3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
-
(4) had no abnormal findings of immune, liver, kidney, or blood function evaluations.
Exclusion Criteria:
-
(1)a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
-
(2) pregnancy or breastfeeding
-
(3) steroid pulse therapy within three months prior to the commencement of our study.
Health Subjects
Inclusion Criteria:
-
(1) aged 20 and 75 years
-
(2) had no chronic inflammatory illness.
Exclusion Criteria:
-
(1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
-
(2) pregnancy or breastfeeding
-
(3) abnormal findings of immune, liver, kidney, or blood function evaluations
-
(4) total sleeping time insufficiency less than 6 hours before one day of enrollment
-
(5) ever took the conventional medicine or hormone within one month
-
(6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ching-Mao Chang | Taipei | Taiwan (r.o.c.) | Taiwan | 112 |
Sponsors and Collaborators
- Taipei Veterans General Hospital, Taiwan
Investigators
- Principal Investigator: Ching-Mao Chang, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-09-006C#3