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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111967
• Other study ID #: PCRG_Metformin_CMG
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: August 12, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Vitamin B 12 Deficiency

Intervention

Other:
• Questionnaire administration

• Laboratory biomarker analysis

Locations

Country	Name	City	State
Switzerland	Pharmaceutical Care Research Group	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Solothurner Spitäler AG, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of serum vitamin B12 and serum holotranscobalamin concentrations	VB12, HoloTc	day 3	No
Secondary	Questionnaire results	Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.	day 8	No