Clinical trial NCT04909489: PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traditional Chinese Medicine
Dyslipidemias
Syndrome
Keywords: metabonomics
syndrome
dislipidemia
serine metabolic pathway
Chinese medicine
PHGDH
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, 240 patients meet the inclusion criteria, including 100 cases of SKYD group and 100 cases of PDR group. Another 40 cases are NC group.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.

Primary outcomes:
measure: Routine Blood Examination
timeFrame: 2 years
measure: Blood Biochemistry
timeFrame: 2 years
measure: Routine Urine Examination
timeFrame: 2 years
measure: the Methylation Level of PHGDH
timeFrame: 2 years
measure: the Methylation Level of PHGDH in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter
timeFrame: 2 years
measure: Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: 3-phosphoglycerate dehydrogenase (PHGDH) RNA
timeFrame: 2 years
measure: 3-phosphoglycerate dehydrogenase (PHGDH) RNA in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Phosphoserine aminotransferase (PSAT1) RNA
timeFrame: 2 years
measure: Phosphoserine aminotransferase (PSAT1) RNA in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Phosphoserine acid phosphatase (PSPH) RNA
timeFrame: 2 years
measure: Phosphoserine acid phosphatase (PSPH) RNA in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Serine
timeFrame: 2 years
measure: the differences of metabonomics in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: the differences of transcriptomics in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: the differences of metabonomics
timeFrame: 2 years
measure: the differences of proteomics in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: the differences of transcriptomics
timeFrame: 2 years
measure: the differences of proteomics
timeFrame: 2 years
measure: Malondialdehyde (MDA) in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Malondialdehyde (MDA)
timeFrame: 2 years
measure: Superoxide Dismutase (SOD) in the cell models of disease-TCM syndrome.
timeFrame: 2 years
measure: Superoxide Dismutase (SOD)
timeFrame: 2 years
measure: Peroxynitrite anion (ONOO-) in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Peroxynitrite anion (ONOO-)
timeFrame: 2 years
measure: Nicotinamide Adenine Dinucleotide Phosphate (NADPH) the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
timeFrame: 2 years
measure: Glutathione (GSH) in the cell models of disease-TCM syndrome.
timeFrame: 2 years
measure: Glutathione (GSH)
timeFrame: 2 years
measure: 3-phosphoglycerate dehydrogenase（PHGDH） in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: 3-phosphoglycerate dehydrogenase（PHGDH）
timeFrame: 2 years
measure: Threonine in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Threonine
timeFrame: 2 years
measure: Glycine in the cell models of disease-TCM syndrome
timeFrame: 2 years
measure: Glycine
timeFrame: 2 years
measure: The clinical TCM scores of SKYD
timeFrame: 2 years
measure: The clinical TCM scores of PDR
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Dongcheng
Study officials:
References: