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

Dyslipidemias Clinical Trial

— PDR SKYD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909489
• Other study ID #: 2021DZMEC-047-02
• Status: Recruiting
• Start date: April 21, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2021
• Source: Dongzhimen Hospital, Beijing
• Contact: Chao Ye, Doctor
• Phone: +8615910603713
• Email: yechao[@]bucm.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Syndrome
• Traditional Chinese Medicine

Intervention

Other:
• cross-sectional study without intervention
cross-sectional study without intervention

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Dongcheng

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Routine Blood Examination	PDR group, SKYD group and NC group's Routine Blood Examination	2 years
Primary	Blood Biochemistry	PDR group, SKYD group and NC group's Blood Biochemistry	2 years
Primary	Routine Urine Examination	PDR group, SKYD group and NC group's Routine Urine Examination	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Phosphoserine aminotransferase (PSAT1) RNA	PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.	2 years
Primary	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
Primary	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
Primary	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
Primary	Serine	Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Malondialdehyde (MDA)	Determination of MDA content by thiobarbituric acid method in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	Superoxide Dismutase (SOD)	Determination of SOD activity by xanthine oxidase method in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	Peroxynitrite anion (ONOO-)	ONOO- will be detected by ELISA in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	Nicotinamide Adenine Dinucleotide Phosphate (NADPH)	NADPH will be detected by ELISA in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	Glutathione (GSH)	GSH will be detected by ELISA in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	3-phosphoglycerate dehydrogenase(PHGDH)	PHGDH will be detected by ELISA in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	Threonine	Threonine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	Glycine	Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.	2 years
Primary	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
Primary	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