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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 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

240

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Dongcheng
      • Beijing, Dongcheng, China, 100700
        • Rekrutierung
        • Dongzhimen Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
NC-Gruppe
Normale Kontrollgruppe
Sonstiges: Querschnittsstudie ohne Intervention
Querschnittsstudie ohne Intervention
PDR group
Phlegm-Dampness Retention syndrome group
Sonstiges: Querschnittsstudie ohne Intervention
Querschnittsstudie ohne Intervention
SKYD group
Spleen and Kidney Yang Deficiency syndrome group
Sonstiges: Querschnittsstudie ohne Intervention
Querschnittsstudie ohne Intervention

Was misst die Studie?

Primäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Dongzhimen Hospital, Beijing

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. April 2021

Primärer Abschluss (Voraussichtlich)

31. März 2023

Studienabschluss (Voraussichtlich)

31. März 2023

Studienanmeldedaten

Zuerst eingereicht

23. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2021

Zuerst gepostet (Tatsächlich)

1. Juni 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. August 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2021

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2021DZMEC-047-02

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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