<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01706887</url>
  </required_header>
  <id_info>
    <org_study_id>P060215</org_study_id>
    <nct_id>NCT01706887</nct_id>
  </id_info>
  <brief_title>Genetic Determinant of Blood Pressure Sensitivity to Salt Intake</brief_title>
  <acronym>JEU004</acronym>
  <official_title>Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt&#xD;
      retention by the kidney. The study address the consequence of a frequent genetic variation&#xD;
      leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to&#xD;
      excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute&#xD;
      a genetic predisposition to (or protection against) salt-sensitive hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were submitted one week to a low sodium-high potassium diet, and then switch to a&#xD;
      high sodium,-low potassium diet for two weeks. the last week, subject were taken a 20 MG&#xD;
      daily dose of amiloride, a potassium sparing diuretic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    end of recruitment period was reach&#xD;
  </why_stopped>
  <start_date>April 2007</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Blood Pressure among genotypes</measure>
    <time_frame>24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks</time_frame>
    <description>24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ambulatory Blood Pressure (AMBP)</measure>
    <time_frame>three weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Diet Amiloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet Amiloride</intervention_name>
    <description>only arm of the trial</description>
    <arm_group_label>Diet Amiloride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
          -  between 18 and 35 years odl&#xD;
&#xD;
          -  BMI between 18 and 28 Kg per m2&#xD;
&#xD;
          -  non smokers&#xD;
&#xD;
          -  no active disease&#xD;
&#xD;
          -  no alcool or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Jeunemaître, PD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>genetic department</affiliation>
  </overall_official>
  <verification_date>March 2012</verification_date>
  <study_first_submitted>April 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nedd4-2</keyword>
  <keyword>blood pressure</keyword>
  <keyword>polymorphism</keyword>
  <keyword>salt intake</keyword>
  <keyword>between 18 and 35 years old</keyword>
  <keyword>BMI between 18 and 28 Kg per m2</keyword>
  <keyword>no active disease</keyword>
  <keyword>no alcool or drug abuse or smoke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amiloride</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706887
org study id: P060215
nct id: NCT01706887
lead sponsor: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: 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
description: 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
measure: Ambulatory Blood Pressure (AMBP)
time frame: three weeks
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
arm group label: Diet Amiloride
arm group type: Experimental
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: Diet Amiloride
description: only arm of the trial
arm group label: Diet Amiloride
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xavier Jeunemaître, PD, PhD
role: Principal Investigator
affiliation: genetic department
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amiloride