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

18. august 2021 opdateret af: Chao Ye, Dongzhimen Hospital, Beijing

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

240

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Dongcheng
      • Beijing, Dongcheng, Kina, 100700
        • Rekruttering
        • Dongzhimen Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
NC gruppe
Normal kontrolgruppe
Andet: tværsnitsundersøgelse uden intervention
tværsnitsundersøgelse uden intervention
PDR group
Phlegm-Dampness Retention syndrome group
Andet: tværsnitsundersøgelse uden intervention
tværsnitsundersøgelse uden intervention
SKYD group
Spleen and Kidney Yang Deficiency syndrome group
Andet: tværsnitsundersøgelse uden intervention
tværsnitsundersøgelse uden intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Routine Blood Examination
Tidsramme: 2 years
PDR group, SKYD group and NC group's Routine Blood Examination
2 years
Blood Biochemistry
Tidsramme: 2 years
PDR group, SKYD group and NC group's Blood Biochemistry
2 years
Routine Urine Examination
Tidsramme: 2 years
PDR group, SKYD group and NC group's Routine Urine Examination
2 years
the Methylation Level of PHGDH
Tidsramme: 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.
2 years
the Methylation Level of PHGDH in the cell models of disease-TCM syndrome
Tidsramme: 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.
2 years
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter
Tidsramme: 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.
2 years
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter in the cell models of disease-TCM syndrome
Tidsramme: 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.
2 years
3-phosphoglycerate dehydrogenase (PHGDH) RNA
Tidsramme: 2 years
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
Tidsramme: 2 years
PHGDH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
2 years
Phosphoserine aminotransferase (PSAT1) RNA
Tidsramme: 2 years
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
Tidsramme: 2 years
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
Tidsramme: 2 years
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
Tidsramme: 2 years
PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
2 years
Serine
Tidsramme: 2 years
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
Tidsramme: 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.
2 years
the differences of transcriptomics in the cell models of disease-TCM syndrome
Tidsramme: 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.
2 years
the differences of metabonomics
Tidsramme: 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.
2 years
the differences of proteomics in the cell models of disease-TCM syndrome
Tidsramme: 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.
2 years
the differences of transcriptomics
Tidsramme: 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.
2 years
the differences of proteomics
Tidsramme: 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.
2 years
Malondialdehyde (MDA) in the cell models of disease-TCM syndrome
Tidsramme: 2 years
Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
2 years
Malondialdehyde (MDA)
Tidsramme: 2 years
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.
Tidsramme: 2 years
Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
2 years
Superoxide Dismutase (SOD)
Tidsramme: 2 years
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
Tidsramme: 2 years
ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
Peroxynitrite anion (ONOO-)
Tidsramme: 2 years
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
Tidsramme: 2 years
NADPH will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
Tidsramme: 2 years
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.
Tidsramme: 2 years
GSH will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
Glutathione (GSH)
Tidsramme: 2 years
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
Tidsramme: 2 years
PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
3-phosphoglycerate dehydrogenase（PHGDH）
Tidsramme: 2 years
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
Tidsramme: 2 years
Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
2 years
Threonine
Tidsramme: 2 years
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
Tidsramme: 2 years
Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
2 years
Glycine
Tidsramme: 2 years
Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
2 years
The clinical TCM scores of SKYD
Tidsramme: 2 years
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
Tidsramme: 2 years
The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dongzhimen Hospital, Beijing

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. april 2021

Primær færdiggørelse (Forventet)

31. marts 2023

Studieafslutning (Forventet)

31. marts 2023

Datoer for studieregistrering

Først indsendt

23. maj 2021

Først indsendt, der opfyldte QC-kriterier

27. maj 2021

Først opslået (Faktiske)

1. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021DZMEC-047-02

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