Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-17 @ 11:17 AM
Study NCT ID:
NCT02111967
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'All blood samples investigated in this study will be destroyed one week after withdrawal. All patient information obtained as a result of the study will be regarded as confidential and made anonymous using a unique study ID number instead of name and surname of the patient.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of serum vitamin B12 and serum holotranscobalamin concentrations', 'timeFrame': 'day 3', 'description': 'VB12, HoloTc'}], 'secondaryOutcomes': [{'measure': 'Questionnaire results', 'timeFrame': 'day 8', 'description': 'Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'In this study we compare the vitamin B12 status by measuring serum vitamin B12 and holotranscobalamin in type 2 diabetic patients with and without metformin treatment. Afterwars we investigate which biomarker could be adequate to reflect B12 status in metformin-treated patients.\n\nWith the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes mellitus type 2 treated with and without Metformin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of T2DM \\> 6 months\n* Metformin treatment for at least 6 months\n* Age \\> 18 years\n* Ability to give written informed consent\n* No metformin treatment in the last 6 months (control group)\n\nExclusion Criteria:\n\n* Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation)\n* Lack of written and/or oral understanding in German, French, Italian or English languages\n* Diagnosis of Transcobolamin transporter defect\n* Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis\n* Diagnosis of Renal disease (Creatinine-Clearance \\<60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases'}, 'identificationModule': {'nctId': 'NCT02111967', 'briefTitle': 'Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement', 'orgStudyIdInfo': {'id': 'PCRG_Metformin_CMG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes mellitus type 2, Metformin', 'description': 'The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin.', 'interventionNames': ['Other: Questionnaire administration', 'Other: Laboratory biomarker analysis']}, {'label': 'Diabetes mellitus type 2', 'description': 'The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment', 'interventionNames': ['Other: Questionnaire administration', 'Other: Laboratory biomarker analysis']}], 'interventions': [{'name': 'Questionnaire administration', 'type': 'OTHER', 'armGroupLabels': ['Diabetes mellitus type 2', 'Diabetes mellitus type 2, Metformin']}, {'name': 'Laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Diabetes mellitus type 2', 'Diabetes mellitus type 2, Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'state': 'Basel', 'country': 'Switzerland', 'facility': 'Pharmaceutical Care Research Group', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Kurt E Hersberger, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmaceutical Care Research Group'}, {'name': 'Philipp N Walter, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmaceutical Care Research Group'}, {'name': 'Gottfried Rudofsky, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kantonsspital Olten'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'Solothurner Spitäler AG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Philipp Walter, PhD', 'investigatorAffiliation': 'University of Basel'}}}}