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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 agosto 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

240

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Dongcheng
      • Beijing, Dongcheng, Cina, 100700
        • Reclutamento
        • Dongzhimen Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Gruppo NC
Gruppo di controllo normale
Altro: studio trasversale senza intervento
studio trasversale senza intervento
PDR group
Phlegm-Dampness Retention syndrome group
Altro: studio trasversale senza intervento
studio trasversale senza intervento
SKYD group
Spleen and Kidney Yang Deficiency syndrome group
Altro: studio trasversale senza intervento
studio trasversale senza intervento

Cosa sta misurando lo studio?

Misure di risultato primarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dongzhimen Hospital, Beijing

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 aprile 2021

Completamento primario (Anticipato)

31 marzo 2023

Completamento dello studio (Anticipato)

31 marzo 2023

Date di iscrizione allo studio

Primo inviato

23 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2021

Primo Inserito (Effettivo)

1 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2021DZMEC-047-02

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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