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Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111967
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : August 13, 2015
Sponsor:
Collaborators:
University of Basel
Solothurner Spitäler AG
Information provided by (Responsible Party):
Philipp Walter, PhD, University of Basel

Study Description
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Brief Summary:

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.

With the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.


Condition or disease Intervention/treatment
Diabetes Mellitus Type 2 Other: Questionnaire administration Other: Laboratory biomarker analysis

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
Drug Information available for: Metformin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Diabetes mellitus type 2, Metformin
The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin.
 Other: Questionnaire administration
Other: 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
 Other: Questionnaire administration
Other: Laboratory biomarker analysis


Outcome Measures
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Primary Outcome Measures :
  1. Measurements of serum vitamin B12 and serum holotranscobalamin concentrations [ Time Frame: day 3 ]
    VB12, HoloTc


Secondary Outcome Measures :
  1. Questionnaire results [ Time Frame: day 8 ]
    Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.


Biospecimen Retention:   None Retained
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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diabetes mellitus type 2 treated with and without Metformin.
Criteria

Inclusion Criteria:

  • Diagnosis of T2DM > 6 months
  • 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:

  • Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111967


Locations
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Switzerland
Pharmaceutical Care Research Group
Basel, Switzerland, 4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Solothurner Spitäler AG
Investigators
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Study Chair: Kurt E Hersberger, Prof. Pharmaceutical Care Research Group
Principal Investigator: Philipp N Walter, Dr. Pharmaceutical Care Research Group
Study Director: Gottfried Rudofsky, Prof. Dr. Kantonsspital Olten
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Philipp Walter, PhD, Dr., University of Basel
ClinicalTrials.gov Identifier: NCT02111967    
Other Study ID Numbers: PCRG_Metformin_CMG
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases