Relation of Blood-boron Levels With Body Mass Index
This study is not yet open for participant recruitment.
Verified July 2011 by SB Istanbul Education and Research Hospital
Sponsor:
SB Istanbul Education and Research Hospital
Information provided by:
SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01400061
First received: July 21, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 21, 2011 | ||||||||
| Last Updated Date | July 21, 2011 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
blood boron level [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] blood boron levels will be measured cantitatively |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
body mass index [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] body mass index levels will be evaluated with blood boron levels |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Relation of Blood-boron Levels With Body Mass Index | ||||||||
| Official Title ICMJE | Phase 1 Study of Blood Boron Levels According to Body Mas Index | ||||||||
| Brief Summary | According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: blood serum analyses |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Normal: 19-24 Overweight: 25-29 Obes: 30-40 Morbid Obes: >40 |
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| Condition ICMJE | Obesity | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01400061 | ||||||||
| Other Study ID Numbers ICMJE | bor1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Bezmialem Vakif University, bezmialem vakif university | ||||||||
| Study Sponsor ICMJE | SB Istanbul Education and Research Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | SB Istanbul Education and Research Hospital | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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