Decode the Environment Variation of Targeted Aldosterone Inducer and siLencer (DETAIL)
Clinical outcome to identify and analyze the epigenetic, phenotypic, protein variation, metabolites of CYP450 Family 11 Subfamily B, both 1 and 2, human-associated aldosterone protein release, and signaling inhibitory pathways post-aldosterone-mineralocorticoid interaction.
We will include clinical studies (RCTs, cohort, case-control/series/report) from fresh human specimens. We will exclude animal studies, studies generated from cell culture, and aldosterone synthesis.
To systematically review and synthesize the literature on the main 2 questions Question 1: Which environment induces CYP11B1 or CYP11B2 activation causing hyperaldosteronemia in hypertension patients? Question 2: Which intracellular signal silences aldosterone-MR activity? For Individual Participant Data Meta-analysis, data will be extracted from final analysis articles from the framework of the data selection process only; the effect measurement and multi-variable model meta-analysis will be performed.
Primary Objective1: to identify CYP450 Family 11 Subfamily B and Aldosterone in hypertension patients following; By structure ● Evidence confirms Epigenetic profile of CYP450 Family 11 Subfamily B, Aldosterone, Signal in hypertension patients, both random and treated from any DNA sequencing method Protein synthesis evidence of aldosterone protein induces hypertension from Western blot or LC-MS By function Metabolomic profile: the substrate or product refers to aldosterone interaction causing end-organ cell line dysfunction or impaired structure.
Inhibitory signaling profiling of hypertension patients compared to non-hypertension patients, which negatively feedback to CYP450 Family 11 Subfamily B or Aldosterone
Secondary Objective 2:
Sub-group analysis effect measurement following;
- Proposed mechanisms, biological markers, or pathways that contribute to failure to regulate aldosteronemia
- Treatment-related permanent normotensive post-hyperaldosteronemia. Primary Objective 2: Identify possible intracellular signal inhibit aldosterone action
- Analyze possible mechanisms of signal that are silent aldosterone-MR activity
- Differentiation of free aldosterone and attached aldosterone
Secondary Objective 2:
● Sensitivity and specificity of outcomes of hypertension patients who underwent estimate substrate associated aldosterone circulation Plasma CYP450 Family 11 Subfamily B Urine CYP450 Family 11 Subfamily B Plasma Aldosterone (active form) Plasma Aldosterone (metabolite form) Urine Aldosterone
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Primary Objective1: to identify CYP450 Family 11 Subfamily B and Aldosterone in hypertension patients following; By structure ● Evidence confirms Epigenetic profile of CYP450 Family 11 Subfamily B, Aldosterone, Signal in hypertension patients, both random and treated from any DNA sequencing method Protein synthesis evidence of aldosterone protein induces hypertension from Western blot or LC-MS By function Metabolomic profile: the substrate or product refers to aldosterone interaction causing end-organ cell line dysfunction or impaired structure.
Inhibitory signaling profiling of hypertension patients compared to non-hypertension patients, which negatively feedback to CYP450 Family 11 Subfamily B or Aldosterone
Secondary Objective 2:
Sub-group analysis effect measurement following;
- Proposed mechanisms, biological markers, or pathways that contribute to failure to regulate aldosteronemia
- Treatment-related permanent normotensive post-hyperaldosteronemia. Primary Objective 2: Identify possible intracellular signal inhibit aldosterone action
- Analyze possible mechanisms of signal that are silent aldosterone-MR activity
- Differentiation of free aldosterone and attached aldosterone
Secondary Objective 2:
● Sensitivity and specificity of outcomes of hypertension patients who underwent estimate substrate associated aldosterone circulation Plasma CYP450 Family 11 Subfamily B Urine CYP450 Family 11 Subfamily B Plasma Aldosterone (active form) Plasma Aldosterone (metabolite form) Urine Aldosterone Axin-CK1-GSK3-APC-Beta-catenin complex
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Nathaphong Dejthida, Medical Degree
- Telefonnummer: +66819220662
- E-Mail: bnnatto@gmail.com
Studienorte
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Bangkok
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Vadhana, Bangkok, Thailand, 10110
- Investigation Center
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Kontakt:
- Nathaphong Dejthida, Medical Degree
- Telefonnummer: +66819220662
- E-Mail: bnnatto@gmail.com
-
Kontakt:
- E-Mail: bnnatto@gmail.com
-
Hauptermittler:
- Nathaphong Dejthida, Medical Degree
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Human birth in all sex chromosomes; evidence of systemic arterial hypertension, both treated and untreated.
- Evidence of living with owned systemic/arterial hypertension by one of the following;
- Quantitative: Blood pressure number higher than the normal range by each protocol in mmHg unit in any arm of study.
- Qualitative: Clarify whether both retrospective, observational, or intervention study of blood pressure, and clearly clarify the number of hypertension participants in the article.
Exclusion Criteria:
- Under 18 years old
- Specimens of studies not from humans or human specimens but not from an actual living hypertension patient, such as cell culture, in vitro synthesis from laboratory synthesis
- No evidence of hypertension in the main study
- Study of imaging confirms adrenal tumor in all types of histopathology results.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Hypertensive Hyperaldosteronemia
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Evidence of synthesis of aldosterone and/or degradation of inactive forms of aldosterone, which focuses on
Medical treatment that interferes with free aldosterone levels and reports systolic blood pressure deviation The non-medical intervention includes MIS, Open surgery, and intravascular guide treatment aim to treat hypetension and lower aldosterone level. |
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Aktiver Komparator: Hypertensive normoaldosteronemia
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Evidence of synthesis of aldosterone and/or degradation of inactive forms of aldosterone, which focuses on
Medical treatment that interferes with free aldosterone levels and reports systolic blood pressure deviation The non-medical intervention includes MIS, Open surgery, and intravascular guide treatment aim to treat hypetension and lower aldosterone level. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Aldosterone circulation profile
Zeitfenster: 12 months
|
The result, both qualitative and quantitative, from aldosterone synthesis to degradation and elimination via urine. |
12 months
|
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Aldoseterone synthesis profile
Zeitfenster: 12 months
|
Focus on both quantitative and qualitative evidence of aldosterone, CYP11B1, andand CYP11B2 protein |
12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Degradation Profile
Zeitfenster: 12 months
|
Focus on the ratio of degradation activity of the inactive form of aldosterone and the inhibitory competitor inhibits the cell product from the aldosterone-mineralocorticoid receptor. Axin-CK1-GSK3-APC complex profile is indicated |
12 months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NDejthida
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The recruitment is published data already
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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