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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Syndrome; Dyslipidemias; Traditional Chinese Medicine
• Intervention / Treatment: Other: cross-sectional study without intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Chao Ye, doctor; Phone Number: +8615910603713; Email: yechao@bucm.edu.cn

Study Locations

• China
  • Dongcheng
    • Beijing, Dongcheng, China, 100700
      • Recruiting
      • Dongzhimen Hospital
      • Contact: Chao Ye, doctor; Phone Number: +8615910603713; Email: yechao@bucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NC group; Normal Control group	Other: cross-sectional study without intervention; cross-sectional study without intervention
PDR group; Phlegm-Dampness Retention syndrome group	Other: cross-sectional study without intervention; cross-sectional study without intervention
SKYD group; Spleen and Kidney Yang Deficiency syndrome group	Other: cross-sectional study without intervention; cross-sectional study without intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Chinese medicine; syndrome; metabonomics; dislipidemia; serine metabolic pathway; PHGDH
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Lipid Metabolism Disorders; Syndrome; Dyslipidemias
• Other Study ID Numbers: 2021DZMEC-047-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No