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

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Other: Questionnaire administration; Other: Laboratory biomarker analysis

• Registration Number: NCT02111967
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus type 2, Metformin	Questionnaire administration	The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin.
Diabetes mellitus type 2	Questionnaire administration	The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment
Diabetes mellitus type 2	Laboratory biomarker analysis	The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment
Diabetes mellitus type 2, Metformin	Laboratory biomarker analysis	The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin.

Primary Outcome Measures

Name	Time	Method
Measurements of serum vitamin B12 and serum holotranscobalamin concentrations	day 3	VB12, HoloTc

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pharmaceutical Care Research Group; 🇨🇭 Basel, Switzerland