- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02129621
Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human
Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is broken up into 5 groups:
The first is a pre-analytical study to determinate optimum conditions for lipocalin samples.
The second focuses on intra-individual variations of lipocalin levels in blood and urine.
The third determinate the normal values of lipocalin in blood and urine. Fourthly, we study the role of renal function on serum and urines lipocalin levels.
Fifthly, we study the role of anti-aldosterone treatment on patients who suffer of primary hyperaldosteronism.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Nancy, Frankreich, 54000
- Brabois Hospital
-
Paris, Frankreich, 75015
- Georges Pompidou Hospital
-
Paris, Frankreich, 75015
- Unit of arterial high blood pressure of the Georges Pompidou Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
For the group 1 and 2
Inclusion criteria:
- Men having an age ranging between 18 and 35 years
- Unhurt subject of any acute pathology for more than 7 days
- Consent signed by the subject
Exclusion criteria:
- Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg) or any cardiovascular history
- Subject presenting a known renal insufficiency
- Subject presenting a known anaemia (Hb < 12g/dl)
- Subject presenting a known diabetes
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Subject presenting a chronic liver disease
- Subject presenting a connectivite: Rhumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Any medicinal treatment
- Subject participating in another protocol or in exclusion's period for another protocol
- Absence of social insurance
For group 3
Inclusion criteria:
- Men or women having an age ranging between 18 and 85 years
- Unhurt subject of any acute pathology for more than 7 days
- without any cardiovascular treatment
- Consent signed by the subject
Exclusion criteria:
- Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg or > 160/95 mmHg after 60 years)
- Subject presenting a known renal insufficiency
- Subject presenting a known diabetes
- Woman who is pregnant
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Subject presenting a chronic liver disease
- Subject presenting a connectivite: Rhumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Subject presenting an effort angor or other coronaropathy
- Subject with antecedant of endarterectomy of carotid
- Subject with known abdominal aorta aneurism
- Subject participating in another protocol or in exclusion's period for another protocol
- Absence of social insurance
For group 4
Inclusion criteria:
- Men or women having an age ranging between 18 and 85 years
- Subject with chronique renal insufficiency
- Consent signed by the subject
Exclusion criteria:
- Subject presenting a known diabetes
- Woman who is pregnant
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Subject presenting a chronic liver disease
- Subject presenting a connectivite: Rhumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Subject presenting an effort angor or other coronaropathy
- Subject with antecedant of endarterectomy of carotid
- Subject with known abdominal aorta aneurism
- Subject participating in another protocol or in exclusion's period for another protocol
- Absence of social insurance
For the group 5
Inclusion Criteria:
- Men or women having an age ranging between 30 and 60 years
- Hypertensive subject suffering from primary hyperaldosteronism defined by an aldosteron/renin ratio > 64 pmol/mL in position lying and an aldosteron level > 500pmol lying down (or > 550pmol/L seated or standing) or urinary aldosteron level > 63 nmol/24 hours; for whom
- Subjects having an indication for a monotherapy treatment by ALDACTONE (1 or 2 mg/kg/j)during preoperative period, possibly associated if need be with a calcic inhibitive treatment, central or alphabloquant treatment.
- Subject without other cardiovascular history (myocardic infarction, decompensation of cardiac insufficiency, intellectual vascular accident) and with a normal renal function according to the age,the sex and the blood value of creatinine by the formula MDRD (Flow of renal filtration > 60mL/min/1,73)
- Consent signed by the subject
Exclusion Criteria:
- Subject presenting others forms of high blood pressure (consumption of products or medicines which can facilitate or deteriorate the high blood pressure (alcohol, licorise (of whom the "pastis" without alcohol), anti-inflammatory drugs, corticosteroids, ciclosporin, erythropoiétin, cocain), hyperthyroidy, hypercorticism, chronic renal disease: urinary protein level < 0.3 g/l and clearance of the creatinine > 60ml/min/1.73m2), arterial renal stenosis
- Counter -indication of realization of a test of salt injection
- Current pregnancy
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Chronic liver disease
- Subject presenting a connectivite: Rheumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Absence of social insurance
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Lipocalin blood and urinary concentrations
Zeitfenster: 8 months
|
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
|
8 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Michel AZIZI, Pr, Georges Pompidou Hospital, Paris
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2007-A01008-45
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 .