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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Glutathione (GSH)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Glutathione (GSH)
时间窗: 2 years
GSH will be detected by ELISA in PDR group, SKYD group and NC group.
Routine Blood Examination
时间窗: 2 years
PDR group, SKYD group and NC group's Routine Blood Examination
Blood Biochemistry
时间窗: 2 years
PDR group, SKYD group and NC group's Blood Biochemistry
Routine Urine Examination
时间窗: 2 years
PDR group, SKYD group and NC group's Routine Urine Examination
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 2 years
PHGDH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Phosphoserine aminotransferase (PSAT1) RNA
时间窗: 2 years
PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Serine
时间窗: 2 years
Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
the differences of metabonomics
时间窗: 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
时间窗: 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
时间窗: 2 years
Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
Phosphoserine acid phosphatase (PSPH) RNA
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
时间窗: 2 years
Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
Superoxide Dismutase (SOD)
时间窗: 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
时间窗: 2 years
ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
Peroxynitrite anion (ONOO-)
时间窗: 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
时间窗: 2 years
PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
时间窗: 2 years
NADPH will be detected by ELISA in PDR group, SKYD group and NC group.
3-phosphoglycerate dehydrogenase（PHGDH）
时间窗: 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
时间窗: 2 years
Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Threonine
时间窗: 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
时间窗: 2 years
Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Glycine
时间窗: 2 years
Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
The clinical TCM scores of SKYD
时间窗: 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
时间窗: 2 years
The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
Chao Ye
Principal Investigator
Dongzhimen Hospital, Beijing