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Genetic Determinant of Blood Pressure Sensitivity to Salt Intake

NCT ID: NCT01706887

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Diet Amiloride

Intervention Type OTHER

only arm of the trial

Interventions

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Diet Amiloride

only arm of the trial

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Jeunemaître, PD, PhD

Role: PRINCIPAL_INVESTIGATOR

genetic department

Other Identifiers

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P060215

Identifier Type: -

Identifier Source: org_study_id