ObesityNCT01400061
Relation of Blood-boron Levels With Body Mass Index
An observational study of Obesity, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2011to Dec 2011
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Normal: 19-24 Overweight: 25-29 Obes: 30-40 Morbid Obes: >40
Who may be able to join
- body mas index levels in over 19 peoples
Who cannot join
- known chronic, morbid and malign diseases
Trial locations and contacts
1 site in 1 country.
erhan aysan, assoc. prof. contact
gokhan cipe, MD contact
About this study
Official title: Phase 1 Study of Blood Boron Levels According to Body Mas Index
According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index.
Read the detailed description
In the results of our experimental study on mices we revealed that low dose oral boric acid intake cause seriously body mas reducing. Although blood and urine analyses support high glucose, lipid and middle protein catabolisms, but the mechanism was unclear. There are some diseases according to blood elementary deficiencies, like hypothyroidi in hypoiyodinemia, hiperparathyroidi in hypocalcemia, etc. We hypothesised that hypoboronemia may be corralated to body mass index level.
- Conditions
- Obesity
- Keywords
- obesity, etiology, pathogenesis, treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal | body mass index: 19-24 | |
| overweight | body mass index: 25-29 | |
| obesity | body mass index: 30-40 | |
| modbid obes | body mass index: over 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood boron level
blood boron levels will be measured cantitatively
Measured: 6 months
Secondary outcomes (1)
body mass index
body mass index levels will be evaluated with blood boron levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- adnan yuksel, prof, Study chair, rector
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400061
- Sponsor's protocol ID
- bor1
- Status last verified
- Jul 2011
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Aysan E, Bektas H, Ersoz F, Sari S, Kaygusuz A. A novel colonic anastomosis technique involving fixed polyglycolic acid mesh. Int J Clin Exp Med. 2010 Oct 24;3(4):341-6.
PubMed 21072268
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Blood Boron Levels According to Body Mas Index
- ClinicalTrials.gov ID
- NCT01400061
- Acronym / sponsor ID
- bor1
- Conditions
- Obesity
- Keywords
- obesity, etiology, pathogenesis, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Jul 2011 (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.
According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index.
Detailed description
In the results of our experimental study on mices we revealed that low dose oral boric acid intake cause seriously body mas reducing. Although blood and urine analyses support high glucose, lipid and middle protein catabolisms, but the mechanism was unclear. There are some diseases according to blood elementary deficiencies, like hypothyroidi in hypoiyodinemia, hiperparathyroidi in hypocalcemia, etc. We hypothesised that hypoboronemia may be corralated to body mass index level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal | – | –body mass index: 19-24 |
| overweight | – | –body mass index: 25-29 |
| obesity | – | –body mass index: 30-40 |
| modbid obes | – | –body mass index: over 40 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal: 19-24 Overweight: 25-29 Obes: 30-40 Morbid Obes: >40
Key inclusion criteria (1 listed)
- body mas index levels in over 19 peoples
Key exclusion criteria (1 listed)
- known chronic, morbid and malign diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood boron level
Time frame: 6 months
blood boron levels will be measured cantitatively
1 secondary outcome
body mass index
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Results publication: PubMed 21072268Aysan E, Bektas H, Ersoz F, Sari S, Kaygusuz A. A novel colonic anastomosis technique involving fixed polyglycolic acid mesh. Int J Clin Exp Med. 2010 Oct 24;3(4):341-6.
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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.
erhan aysan, assoc. prof. contact
gokhan cipe, MD contact
adnan yuksel, prof study chair
rector
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2011. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erhan aysan, assoc. prof. (+902124531700), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood boron level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400061, which also lists 1 linked publication.
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 22 Jul 2011.