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Genetic Determinant of Blood Pressure Sensitivity to Salt Intake (JEU004)

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ClinicalTrials.gov Identifier: NCT01706887
Recruitment Status : Terminated (end of recruitment period was reach)
First Posted : October 15, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt retention by the kidney. The study address the consequence of a frequent genetic variation leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute a genetic predisposition to (or protection against) salt-sensitive hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Other: Diet Amiloride Not Applicable

Detailed Description:
Subjects were submitted one week to a low sodium-high potassium diet, and then switch to a high sodium,-low potassium diet for two weeks. the last week, subject were taken a 20 MG daily dose of amiloride, a potassium sparing diuretic.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel
Study Start Date : April 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diet Amiloride
One week Low Na diet (10 mmol/d) followed by ine week high Na diet (200 mmol/d) followed by 2 weeks administration of amiloride (10 mg the 1 st week and the 20mg).
Other: Diet Amiloride
only arm of the trial



Primary Outcome Measures :
  1. Difference in Blood Pressure among genotypes [ Time Frame: 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks ]
    24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks


Secondary Outcome Measures :
  1. Ambulatory Blood Pressure (AMBP) [ Time Frame: three weeks ]
    24h AMBP was measured fourth : at the beginning of the study,at the end of the low sodium-high potassium diet, after one week under the high sodium-low potassium diet and at the end of amiloride treatment under high sodium-low potassium diet



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • between 18 and 35 years odl
  • BMI between 18 and 28 Kg per m2
  • non smokers
  • no active disease
  • no alcool or drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706887


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier Jeunemaître, PD, PhD genetic department

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01706887     History of Changes
Other Study ID Numbers: P060215
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: March 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nedd4-2
blood pressure
polymorphism
salt intake
between 18 and 35 years old
BMI between 18 and 28 Kg per m2
no active disease
no alcool or drug abuse or smoke

Additional relevant MeSH terms:
Amiloride
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing