ObesityPhase 2PLADSELNCT01532401
Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers
A Phase 2 study testing sodium chloride and Methylcellulose crystalline in people with Obesity, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- sodium chloride and Methylcellulose crystalline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Age 18-45 for adults and 6-8 for children
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult
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.
- Conditions
- Obesity
- Being tested
- sodium chloride, Methylcellulose crystalline
- Keywords
- Blood pressure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium chlorideOther
sodium chloride 500mg
Methylcellulose crystallineOther
Methylcellulose 37 ml
| Study group | Role | What they receive |
|---|---|---|
| chlorure de sodium | Experimental | Not described Receives: Other: sodium chloride |
| Methylcellulose | Placebo comparator | Not described Receives: Other: Methylcellulose crystalline |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samy HADJADJ, MD, Principal investigator, CHU DE POITIERS-Service d'endocrinologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532401
- Sponsor's protocol ID
- PLADSEL 2010-023410-31
- Acronym
- PLADSEL
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult
- ClinicalTrials.gov ID
- NCT01532401
- Acronym / sponsor ID
- PLADSEL / PLADSEL 2010-023410-31
- Conditions
- Obesity
- Keywords
- Blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2014 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorure de sodium | Experimental | Other: sodium chloride |
| Methylcellulose | Placebo comparator | Other: Methylcellulose crystalline |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Informed consent
- Age 18-45 for adults and 6-8 for children
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium chloridesodium chloride 500mg | Other | chlorure de sodium |
| Methylcellulose crystallineMethylcellulose 37 ml | Other | Methylcellulose |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samy HADJADJ, MD principal investigator
CHU DE POITIERS-Service d'endocrinologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium chloride and Methylcellulose crystalline in people with Obesity, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.