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Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human

1. maj 2014 opdateret af: Central Hospital, Nancy, France

Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.

Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Nancy, Frankrig, 54000
        • Brabois Hospital
      • Paris, Frankrig, 75015
        • Georges Pompidou Hospital
      • Paris, Frankrig, 75015
        • Unit of arterial high blood pressure of the Georges Pompidou Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lipocalin blood and urinary concentrations
Tidsramme: 8 months
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
8 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Michel AZIZI, Pr, Georges Pompidou Hospital, Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

30. april 2014

Først indsendt, der opfyldte QC-kriterier

1. maj 2014

Først opslået (Skøn)

2. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2014

Sidst verificeret

1. januar 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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