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

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ClinicalTrials.gov Identifier: NCT01532401
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Other: sodium chloride Other: Methylcellulose crystalline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Official Title: Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult
Study Start Date : March 2011
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: chlorure de sodium Other: sodium chloride
sodium chloride 500mg

Placebo Comparator: Methylcellulose Other: Methylcellulose crystalline
Methylcellulose 37 ml





Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01532401


Locations
France
Poitiers University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: Samy HADJADJ, MD CHU DE POITIERS-Service d'endocrinologie

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01532401     History of Changes
Other Study ID Numbers: PLADSEL 2010-023410-31
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: February 2012

Keywords provided by Poitiers University Hospital:
Blood pressure