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

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet Amiloride
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring 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

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diet Amiloride

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Difference in Blood Pressure among genotypes
    24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks

    Secondary Outcome Measures

    Ambulatory Blood Pressure (AMBP)
    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

    Full Information

    First Posted
    April 27, 2012
    Last Updated
    October 12, 2012
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01706887
    Brief Title
    Genetic Determinant of Blood Pressure Sensitivity to Salt Intake
    Acronym
    JEU004
    Official Title
    Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Terminated
    Why Stopped
    end of recruitment period was reach
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    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

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    219 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diet Amiloride
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Diet Amiloride
    Intervention Description
    only arm of the trial
    Primary Outcome Measure Information:
    Title
    Difference in Blood Pressure among genotypes
    Description
    24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
    Time Frame
    24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
    Secondary Outcome Measure Information:
    Title
    Ambulatory Blood Pressure (AMBP)
    Description
    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
    Time Frame
    three weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xavier Jeunemaître, PD, PhD
    Organizational Affiliation
    genetic department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Genetic Determinant of Blood Pressure Sensitivity to Salt Intake

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