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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02111967

Enrollment

Registered

2014-04-11

Start date

2014-03-31

Completion date

2014-12-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

OTHERQuestionnaire administration

OTHERLaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Questionnaire results	day 8	Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026