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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. srpna 2021 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Očekávaný)

240

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Dongcheng
      • Beijing, Dongcheng, Čína, 100700
        • Nábor
        • Dongzhimen Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
NC skupina
Normální kontrolní skupina
Jiný: průřezová studie bez intervence
průřezová studie bez intervence
PDR group
Phlegm-Dampness Retention syndrome group
Jiný: průřezová studie bez intervence
průřezová studie bez intervence
SKYD group
Spleen and Kidney Yang Deficiency syndrome group
Jiný: průřezová studie bez intervence
průřezová studie bez intervence

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Routine Blood Examination
Časové okno: 2 years
PDR group, SKYD group and NC group's Routine Blood Examination
2 years
Blood Biochemistry
Časové okno: 2 years
PDR group, SKYD group and NC group's Blood Biochemistry
2 years
Routine Urine Examination
Časové okno: 2 years
PDR group, SKYD group and NC group's Routine Urine Examination
2 years
the Methylation Level of PHGDH
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 2 years
PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
2 years
Serine
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 2 years
Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
2 years
Malondialdehyde (MDA)
Časové okno: 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.
Časové okno: 2 years
Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
2 years
Superoxide Dismutase (SOD)
Časové okno: 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
Časové okno: 2 years
ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
Peroxynitrite anion (ONOO-)
Časové okno: 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
Časové okno: 2 years
NADPH will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
Časové okno: 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.
Časové okno: 2 years
GSH will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
Glutathione (GSH)
Časové okno: 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
Časové okno: 2 years
PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
2 years
3-phosphoglycerate dehydrogenase（PHGDH）
Časové okno: 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
Časové okno: 2 years
Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
2 years
Threonine
Časové okno: 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
Časové okno: 2 years
Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
2 years
Glycine
Časové okno: 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
Časové okno: 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
Časové okno: 2 years
The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
2 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Dongzhimen Hospital, Beijing

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. dubna 2021

Primární dokončení (Očekávaný)

31. března 2023

Dokončení studie (Očekávaný)

31. března 2023

Termíny zápisu do studia

První předloženo

23. května 2021

První předloženo, které splnilo kritéria kontroly kvality

27. května 2021

První zveřejněno (Aktuální)

1. června 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. srpna 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. srpna 2021

Naposledy ověřeno

1. srpna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2021DZMEC-047-02

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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