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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

Laboratory biomarker analysis

Intervention Type OTHER

Diabetes mellitus type 2

The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment

Questionnaire administration

Intervention Type OTHER

Laboratory biomarker analysis

Intervention Type OTHER

Interventions

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Questionnaire administration

Intervention Type OTHER

Laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

Solothurner Spitäler AG

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Philipp Walter, PhD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Switzerland

Other Identifiers

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PCRG_Metformin_CMG

Identifier Type: -

Identifier Source: org_study_id

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