PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway

Study Overview
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Brief Summary
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Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and disease syndrome cell model will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.

Detailed Description
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Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and disease syndrome cell model will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.

Official Title
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Study on the Characteristics of Phlegm-Dampness Retention Syndrome and the Spleen and Kidney Yang Deficiency of Dyslipidemia From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway

Conditions
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Traditional Chinese Medicine, Dyslipidemias, Syndrome

Intervention / Treatment
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* Other: cross-sectional study without intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inclusion criteria of dyslipidemia with SKYD and PDR. (1) subjects with dyslipidemia in accordance with the diagnostic standards and TCM syndrome diagnostic standards, (2) ranged in age from 20 to 80, (3) who signed the informed consent, and (4) without lipid-lowering medications. inclusion criteria of NC. (1) healthy subjects, (2) ranged in age from 20 to 80, (3) who signed the informed consent. Exclusion criteria: Exclusion criteria of dyslipidemia with SKYD and PDR. The exclusion criteria were composed of four criteria and a patient was excluded if they fails on any of the criteria. Mentioned criteria were: (1) secondary dyslipidemia (causes of dyslipidemia include but not limited to hypothyroidism, nephrotic syndrome, chronic renal failure, liver diseases, diseases of the hematopoietic system, adrenal-corticosteroid or contraceptive-drug induced dyslipidemia); (2) aphasias, and patients had difficulties to speak or unable to extend tongue for tongue observation; (3) patients with psychosis or unable to answer questions properly; (4) patients with acute infectious diseases or in the acute disease states (such as acute myocardial infarction, acute cerebrovascular disease, etc.), as well as pregnant women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PDR group<br>Phlegm-Dampness Retention syndrome group | Other: cross-sectional study without intervention<br>* cross-sectional study without intervention<br>|
| SKYD group<br>Spleen and Kidney Yang Deficiency syndrome group | Other: cross-sectional study without intervention<br>* cross-sectional study without intervention<br>|
| NC group<br>Normal Control group | Other: cross-sectional study without intervention<br>* cross-sectional study without intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine Blood Examination | PDR group, SKYD group and NC group's Routine Blood Examination | 2 years | 
| Blood Biochemistry | PDR group, SKYD group and NC group's Blood Biochemistry | 2 years | 
| Routine Urine Examination | PDR group, SKYD group and NC group's Routine Urine Examination | 2 years | 
| the Methylation Level of PHGDH | Methylation sensitive restriction enzyme technique combined with PCR (msre-pcr) will be used to detect the Methylation Level of PHGDH in PDR group, SKYD group and NC group. | 2 years | 
| the Methylation Level of PHGDH in the cell models of disease-TCM syndrome | Methylation sensitive restriction enzyme technique combined with PCR (msre-pcr) will be used to detect the Methylation Level of PHGDH in the cell models of disease-TCM syndrome. | 2 years | 
| Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter | The distribution of h3k4me3, H3K9Ac and h3k27ac histones in the promoter of PHGDH gene will be detected by chromatin immunoprecipitation assay (chip) in PDR group, SKYD group and NC group. | 2 years | 
| Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter in the cell models of disease-TCM syndrome | The distribution of h3k4me3, H3K9Ac and h3k27ac histones in the promoter of PHGDH gene will be detected by chromatin immunoprecipitation assay (chip) in the cell models of disease-TCM syndrome. | 2 years | 
| 3-phosphoglycerate dehydrogenase (PHGDH) RNA | PHGDH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group. | 2 years | 
| 3-phosphoglycerate dehydrogenase (PHGDH) RNA in the cell models of disease-TCM syndrome | PHGDH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome. | 2 years | 
| Phosphoserine aminotransferase (PSAT1) RNA | PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome. | 2 years | 
| Phosphoserine aminotransferase (PSAT1) RNA in the cell models of disease-TCM syndrome | PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome. | 2 years | 
| Phosphoserine acid phosphatase (PSPH) RNA | PSPH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group. | 2 years | 
| Phosphoserine acid phosphatase (PSPH) RNA in the cell models of disease-TCM syndrome | PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome. | 2 years | 
| Serine | Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group. | 2 years | 
| the differences of metabonomics in the cell models of disease-TCM syndrome | The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in the cell models of disease-TCM syndrome. | 2 years | 
| the differences of transcriptomics in the cell models of disease-TCM syndrome | The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in the cell models of disease-TCM syndrome. | 2 years | 
| the differences of metabonomics | The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in PDR group, SKYD group and NC group. | 2 years | 
| the differences of proteomics in the cell models of disease-TCM syndrome | The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in the cell models of disease-TCM syndrome. | 2 years | 
| the differences of transcriptomics | The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in PDR group, SKYD group and NC group. | 2 years | 
| the differences of proteomics | The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in PDR group, SKYD group and NC group. | 2 years | 
| Malondialdehyde (MDA) in the cell models of disease-TCM syndrome | Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome. | 2 years | 
| Malondialdehyde (MDA) | Determination of MDA content by thiobarbituric acid method in PDR group, SKYD group and NC group. | 2 years | 
| Superoxide Dismutase (SOD) in the cell models of disease-TCM syndrome. | Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome. | 2 years | 
| Superoxide Dismutase (SOD) | Determination of SOD activity by xanthine oxidase method in PDR group, SKYD group and NC group. | 2 years | 
| Peroxynitrite anion (ONOO-) in the cell models of disease-TCM syndrome | ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome. | 2 years | 
| Peroxynitrite anion (ONOO-) | ONOO- will be detected by ELISA in PDR group, SKYD group and NC group. | 2 years | 
| Nicotinamide Adenine Dinucleotide Phosphate (NADPH) the cell models of disease-TCM syndrome | NADPH will be detected by ELISA in the cell models of disease-TCM syndrome. | 2 years | 
| Nicotinamide Adenine Dinucleotide Phosphate (NADPH) | NADPH will be detected by ELISA in PDR group, SKYD group and NC group. | 2 years | 
| Glutathione (GSH) in the cell models of disease-TCM syndrome. | GSH will be detected by ELISA in the cell models of disease-TCM syndrome. | 2 years | 
| Glutathione (GSH) | GSH will be detected by ELISA in PDR group, SKYD group and NC group. | 2 years | 
| 3-phosphoglycerate dehydrogenase（PHGDH） in the cell models of disease-TCM syndrome | PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome. | 2 years | 
| 3-phosphoglycerate dehydrogenase（PHGDH） | PHGDH will be detected by ELISA in PDR group, SKYD group and NC group. | 2 years | 
| Threonine in the cell models of disease-TCM syndrome | Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome. | 2 years | 
| Threonine | Threonine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group. | 2 years | 
| Glycine in the cell models of disease-TCM syndrome | Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome. | 2 years | 
| Glycine | Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group. | 2 years | 
| The clinical TCM scores of SKYD | The minimum value is 0 and maximum value is 35, and higher scores mean a worse outcome. | 2 years | 
| The clinical TCM scores of PDR | The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabonomics, syndrome, dislipidemia, serine metabolic pathway, Chinese medicine, PHGDH