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

NCT04909489 | Unknown

• 1 other identifier: 2021DZMEC-047-02
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Traditional Chinese Medicine; Dyslipidemias; Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (38)

• 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

Study Arms (3)

PDR group

Phlegm-Dampness Retention syndrome group

Other: cross-sectional study without intervention

SKYD group

Spleen and Kidney Yang Deficiency syndrome group

Other: cross-sectional study without intervention

NC group

Normal Control group

Other: cross-sectional study without intervention

Interventions

cross-sectional study without intervention OTHER

cross-sectional study without intervention

NC group; PDR group; SKYD group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital

Beijing, Dongcheng, 100700, China

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Syndrome

Interventions

Cross-Sectional Studies; Methods

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Chao Ye, Doctor

CONTACT

+8615910603713; yechao@bucm.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 1, 2021
• Study Start: April 21, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (1)