PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway
- Conditions
- SyndromeTraditional Chinese MedicineDyslipidemias
- Interventions
- Other: cross-sectional study without intervention
- Registration Number
- NCT04909489
- Lead Sponsor
- Dongzhimen Hospital, Beijing
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NC group cross-sectional study without intervention Normal Control group PDR group cross-sectional study without intervention Phlegm-Dampness Retention syndrome group SKYD group cross-sectional study without intervention Spleen and Kidney Yang Deficiency syndrome group
- Primary Outcome Measures
Name Time Method Routine Blood Examination 2 years PDR group, SKYD group and NC group's Routine Blood Examination
Glutathione (GSH) 2 years GSH will be detected by ELISA in PDR group, SKYD group and NC group.
Blood Biochemistry 2 years PDR group, SKYD group and NC group's Blood Biochemistry
Routine Urine Examination 2 years PDR group, SKYD group and NC group's Routine Urine Examination
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter 2 years 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.
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter in the cell models of disease-TCM syndrome 2 years 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.
the Methylation Level of PHGDH in the cell models of disease-TCM syndrome 2 years 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.
Phosphoserine aminotransferase (PSAT1) RNA in the cell models of disease-TCM syndrome 2 years PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
the Methylation Level of PHGDH 2 years 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.
3-phosphoglycerate dehydrogenase (PHGDH) RNA 2 years PHGDH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group.
3-phosphoglycerate dehydrogenase (PHGDH) RNA in the cell models of disease-TCM syndrome 2 years PHGDH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Phosphoserine aminotransferase (PSAT1) RNA 2 years PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Serine 2 years Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
the differences of metabonomics 2 years The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in PDR group, SKYD group and NC group.
the differences of transcriptomics 2 years The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in PDR group, SKYD group and NC group.
Malondialdehyde (MDA) in the cell models of disease-TCM syndrome 2 years Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
Phosphoserine acid phosphatase (PSPH) RNA 2 years PSPH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group.
Phosphoserine acid phosphatase (PSPH) RNA in the cell models of disease-TCM syndrome 2 years PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
the differences of metabonomics in the cell models of disease-TCM syndrome 2 years The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in the cell models of disease-TCM syndrome.
the differences of proteomics in the cell models of disease-TCM syndrome 2 years The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in the cell models of disease-TCM syndrome.
Nicotinamide Adenine Dinucleotide Phosphate (NADPH) the cell models of disease-TCM syndrome 2 years NADPH will be detected by ELISA in the cell models of disease-TCM syndrome.
Glutathione (GSH) in the cell models of disease-TCM syndrome. 2 years GSH will be detected by ELISA in the cell models of disease-TCM syndrome.
the differences of transcriptomics in the cell models of disease-TCM syndrome 2 years The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in the cell models of disease-TCM syndrome.
the differences of proteomics 2 years The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in PDR group, SKYD group and NC group.
Malondialdehyde (MDA) 2 years Determination of MDA content by thiobarbituric acid method in PDR group, SKYD group and NC group.
Superoxide Dismutase (SOD) in the cell models of disease-TCM syndrome. 2 years Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
Superoxide Dismutase (SOD) 2 years Determination of SOD activity by xanthine oxidase method in PDR group, SKYD group and NC group.
Peroxynitrite anion (ONOO-) in the cell models of disease-TCM syndrome 2 years ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
Peroxynitrite anion (ONOO-) 2 years ONOO- will be detected by ELISA in PDR group, SKYD group and NC group.
3-phosphoglycerate dehydrogenase（PHGDH） in the cell models of disease-TCM syndrome 2 years PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
Nicotinamide Adenine Dinucleotide Phosphate (NADPH) 2 years NADPH will be detected by ELISA in PDR group, SKYD group and NC group.
3-phosphoglycerate dehydrogenase（PHGDH） 2 years PHGDH will be detected by ELISA in PDR group, SKYD group and NC group.
Threonine in the cell models of disease-TCM syndrome 2 years Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Threonine 2 years Threonine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
Glycine in the cell models of disease-TCM syndrome 2 years Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Glycine 2 years Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
The clinical TCM scores of SKYD 2 years The minimum value is 0 and maximum value is 35, and higher scores mean a worse outcome.
The clinical TCM scores of PDR 2 years The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dongzhimen Hospital
🇨🇳Beijing, Dongcheng, China