Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers

NCT ID: NCT01532401

Last Updated: 2016-10-11

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese.

Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.

Detailed Description

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Conditions

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Obesity

Study Groups

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chlorure de sodium

Group Type EXPERIMENTAL

sodium chloride

Intervention Type OTHER

sodium chloride 500mg

Methylcellulose

Group Type PLACEBO_COMPARATOR

Methylcellulose crystalline

Intervention Type OTHER

Methylcellulose 37 ml

Interventions

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sodium chloride

sodium chloride 500mg

Intervention Type OTHER

Methylcellulose crystalline

Methylcellulose 37 ml

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Age 18-45 for adults and 6-8 for children

Exclusion Criteria

* African ethnicity (known to affect blood pressure sensitivity to salt)
* Chronic condition affecting blood pressure
* Diabetes (known to affect blood pressure sensitivity to salt)
* Hypertension
Minimum Eligible Age

6 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samy HADJADJ, MD

Role: PRINCIPAL_INVESTIGATOR

CHU DE POITIERS-Service d'endocrinologie

Locations

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Poitiers University Hospital

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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PLADSEL 2010-023410-31

Identifier Type: -

Identifier Source: org_study_id

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