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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02111967
Other study ID # PCRG_Metformin_CMG
Secondary ID
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


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
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