PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway (PDR SKYD)
18 août 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
240
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Chao Ye, doctor
- Numéro de téléphone: +8615910603713
- E-mail: yechao@bucm.edu.cn
Lieux d'étude
-
-
Dongcheng
-
Beijing, Dongcheng, Chine, 100700
- Recrutement
- Dongzhimen Hospital
-
Contact:
- Chao Ye, doctor
- Numéro de téléphone: +8615910603713
- E-mail: yechao@bucm.edu.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
Inclusion Criteria:
- 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.
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Groupe CN
Groupe de contrôle normal
|
étude transversale sans intervention
|
|
PDR group
Phlegm-Dampness Retention syndrome group
|
étude transversale sans intervention
|
|
SKYD group
Spleen and Kidney Yang Deficiency syndrome group
|
étude transversale sans intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Routine Blood Examination
Délai: 2 years
|
PDR group, SKYD group and NC group's Routine Blood Examination
|
2 years
|
|
Blood Biochemistry
Délai: 2 years
|
PDR group, SKYD group and NC group's Blood Biochemistry
|
2 years
|
|
Routine Urine Examination
Délai: 2 years
|
PDR group, SKYD group and NC group's Routine Urine Examination
|
2 years
|
|
the Methylation Level of PHGDH
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 2 years
|
PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
|
2 years
|
|
Serine
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 2 years
|
Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
|
2 years
|
|
Malondialdehyde (MDA)
Délai: 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.
Délai: 2 years
|
Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
|
2 years
|
|
Superoxide Dismutase (SOD)
Délai: 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
Délai: 2 years
|
ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
|
2 years
|
|
Peroxynitrite anion (ONOO-)
Délai: 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
Délai: 2 years
|
NADPH will be detected by ELISA in the cell models of disease-TCM syndrome.
|
2 years
|
|
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
Délai: 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.
Délai: 2 years
|
GSH will be detected by ELISA in the cell models of disease-TCM syndrome.
|
2 years
|
|
Glutathione (GSH)
Délai: 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
Délai: 2 years
|
PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
|
2 years
|
|
3-phosphoglycerate dehydrogenase（PHGDH）
Délai: 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
Délai: 2 years
|
Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
|
2 years
|
|
Threonine
Délai: 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
Délai: 2 years
|
Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
|
2 years
|
|
Glycine
Délai: 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
Délai: 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
Délai: 2 years
|
The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
|
2 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 avril 2021
Achèvement primaire (Anticipé)
31 mars 2023
Achèvement de l'étude (Anticipé)
31 mars 2023
Dates d'inscription aux études
Première soumission
23 mai 2021
Première soumission répondant aux critères de contrôle qualité
27 mai 2021
Première publication (Réel)
1 juin 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 août 2021
Dernière vérification
1 août 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021DZMEC-047-02
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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