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

University Hospital Basel

Status

Completed

Conditions

Diabetes Mellitus Type 2

Treatments

Other: Laboratory biomarker analysis

Other: Questionnaire administration

Study type

Observational

Funder types

Other

Identifiers

NCT02111967

PCRG_Metformin_CMG

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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