Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-06 @ 9:54 AM
Study NCT ID:
NCT01400061
Status:
UNKNOWN
Last Update Posted:
2011-07-22
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation of Blood-boron Levels With Body Mass Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood serum analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood boron level', 'timeFrame': '6 months', 'description': 'blood boron levels will be measured cantitatively'}], 'secondaryOutcomes': [{'measure': 'body mass index', 'timeFrame': '6 months', 'description': 'body mass index levels will be evaluated with blood boron levels'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity, etiology, pathogenesis, treatment'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '21072268', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Normal: 19-24 Overweight: 25-29 Obes: 30-40 Morbid Obes: \\>40', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mas index levels in over 19 peoples\n\nExclusion Criteria:\n\n* known chronic, morbid and malign diseases'}, 'identificationModule': {'nctId': 'NCT01400061', 'briefTitle': 'Relation of Blood-boron Levels With Body Mass Index', 'organization': {'class': 'OTHER', 'fullName': 'SB Istanbul Education and Research Hospital'}, 'officialTitle': 'Phase 1 Study of Blood Boron Levels According to Body Mas Index', 'orgStudyIdInfo': {'id': 'bor1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal', 'description': 'body mass index: 19-24'}, {'label': 'overweight', 'description': 'body mass index: 25-29'}, {'label': 'obesity', 'description': 'body mass index: 30-40'}, {'label': 'modbid obes', 'description': 'body mass index: over 40'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34543', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'erhan aysan, assoc. prof.', 'role': 'CONTACT', 'phone': '+902124531700'}, {'name': 'gokhan cipe, MD', 'role': 'CONTACT', 'phone': '+902124531700'}], 'overallOfficials': [{'name': 'adnan yuksel, prof', 'role': 'STUDY_CHAIR', 'affiliation': 'rector'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Istanbul Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bezmialem Vakif University', 'oldOrganization': 'bezmialem vakif university'}}}}