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

August 12, 2015 updated by: Philipp Walter, PhD, University Hospital, Basel, Switzerland

Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • Pharmaceutical Care Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with diabetes mellitus type 2 treated with and without Metformin.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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: Laboratory biomarker analysis
Other: Questionnaire administration
Diabetes mellitus type 2
The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment
Other: Laboratory biomarker analysis
Other: Questionnaire administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of serum vitamin B12 and serum holotranscobalamin concentrations
Time Frame: day 3
VB12, HoloTc
day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University of Basel
Solothurner Spitäler AG

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCRG_Metformin_CMG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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