Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers (PLADSEL)
This study is currently recruiting participants.
Verified February 2012 by Poitiers University Hospital
Sponsor:
Poitiers University Hospital
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01532401
First received: February 9, 2012
Last updated: February 13, 2012
Last verified: February 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obesity |
Other: sodium chloride Other: Methylcellulose crystalline |
Phase 2 |
| Study Type: | Interventional |
| Official Title: | Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult |
Resource links provided by NLM:
Further study details as provided by Poitiers University Hospital:
| Arms | Assigned Interventions |
|---|---|
| Experimental: chlorure de sodium |
Other: sodium chloride
sodium chloride 500mg
|
| Placebo Comparator: Methylcellulose |
Other: Methylcellulose crystalline
Methylcellulose 37 ml
|
Eligibility| Ages Eligible for Study: | 6 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532401
Contacts
| Contact: Samy HADJADJ, MD | 0549443043 | samy.hadjadj@chu-poitiers.fr |
Locations
| France | |
| Poitiers University Hospital | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Samy HADJADJ, MD 0549443043 samy.hadjadj@chu-poitiers.fr | |
Sponsors and Collaborators
Poitiers University Hospital
Investigators
| Principal Investigator: | Samy HADJADJ, MD | CHU DE POITIERS-Service d'endocrinologie |
More Information
No publications provided
| Responsible Party: | Poitiers University Hospital |
| ClinicalTrials.gov Identifier: | NCT01532401 History of Changes |
| Other Study ID Numbers: | PLADSEL 2010-023410-31 |
| Study First Received: | February 9, 2012 |
| Last Updated: | February 13, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Poitiers University Hospital:
|
Blood pressure |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013