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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04909489

Acronym

PDR SKYD

Enrollment

240

Registered

2021-06-01

Start date

2021-04-21

Completion date

2023-03-31

Last updated

2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Syndrome, Traditional Chinese Medicine

Keywords

metabonomics, syndrome, dislipidemia, serine metabolic pathway, Chinese medicine, PHGDH

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

Interventions

OTHERcross-sectional study without intervention

cross-sectional study without intervention

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
Routine Blood Examination	2 years	PDR group, SKYD group and NC group's Routine Blood Examination
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
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.
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.
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.
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.
Superoxide Dismutase (SOD)	2 years	Determination of SOD activity by xanthine oxidase method in PDR group, SKYD group and NC group.
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.
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.
Serine	2 years	Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
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 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 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 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.
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.
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) 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.
Malondialdehyde (MDA)	2 years	Determination of MDA content by thiobarbituric acid 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.
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.
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)	2 years	NADPH will be detected by ELISA in PDR group, SKYD group and NC group.
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.
Glutathione (GSH)	2 years	GSH 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.
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.

Countries

China

Contacts

Primary ContactChao Ye, Doctor

yechao@bucm.edu.cn+8615910603713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026