Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin
NCT ID: NCT02111967
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2014-03-31
2014-12-31
Brief Summary
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With the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Diabetes mellitus type 2, Metformin
The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin.
Questionnaire administration
Laboratory biomarker analysis
Diabetes mellitus type 2
The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment
Questionnaire administration
Laboratory biomarker analysis
Interventions
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Questionnaire administration
Laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Metformin treatment for at least 6 months
* Age \> 18 years
* Ability to give written informed consent
* No metformin treatment in the last 6 months (control group)
Exclusion Criteria
* Lack of written and/or oral understanding in German, French, Italian or English languages
* Diagnosis of Transcobolamin transporter defect
* Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis
* Diagnosis of Renal disease (Creatinine-Clearance \<60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases
18 Years
ALL
No
Sponsors
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University of Basel
OTHER
Solothurner Spitäler AG
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Philipp Walter, PhD
Dr.
Principal Investigators
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Kurt E Hersberger, Prof.
Role: STUDY_CHAIR
Pharmaceutical Care Research Group
Philipp N Walter, Dr.
Role: PRINCIPAL_INVESTIGATOR
Pharmaceutical Care Research Group
Gottfried Rudofsky, Prof. Dr.
Role: STUDY_DIRECTOR
Kantonsspital Olten
Locations
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Pharmaceutical Care Research Group
Basel, Basel, Switzerland
Countries
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Other Identifiers
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PCRG_Metformin_CMG
Identifier Type: -
Identifier Source: org_study_id
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