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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02129621

Enrollment

Registered

2014-05-02

Start date

2010-05-31

Completion date

2012-11-30

Last updated

2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Lipocalin, mineralocorticoid receptor

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREUrinary and blood lipococalin levels determination

Blood test on an empty stomach. Urinary taking on arrival in the service

DRUGSpironolactone

For the group 5, at the time of the V0 visit, a treatment by aldactone will be set up (posology: 1 to 2 mg/kg).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Lipocalin blood and urinary concentrations	8 months	Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026