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NCT Number: NCT02111967

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pharmaceutical Care Research Group

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Measurements of serum vitamin B12 and serum holotranscobalamin concentrations

    Time frame: day 3

    VB12, HoloTc

Secondary outcomes

  1. Questionnaire results

    Time frame: day 8

    Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Solothurner Spitäler AG
  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2014
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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