Trial record 16 of 116 for:    vitamin B12 deficiency

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
University of Basel
Solothurner Spitäler AG
Information provided by (Responsible Party):
Philipp Walter, PhD, University of Basel
ClinicalTrials.gov Identifier:
NCT02111967
First received: April 9, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2
Other: Questionnaire administration
Other: Laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adequacy of Serum Vitamin B12 Meausrement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Measurements of serum vitamin B12 and serum holotranscobalamin concentrations [ Time Frame: day 3 ] [ Designated as safety issue: No ]
    VB12, HoloTc


Secondary Outcome Measures:
  • Questionnaire results [ Time Frame: day 8 ] [ Designated as safety issue: No ]
    Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.


Biospecimen Retention:   None Retained

All blood samples investigated in this study will be destroyed one week after withdrawal. All patient information obtained as a result of the study will be regarded as confidential and made anonymous using a unique study ID number instead of name and surname of the patient.


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diabetes mellitus type 2, Metformin
The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin.
Other: Questionnaire administration Other: Laboratory biomarker analysis
Diabetes mellitus type 2
The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment
Other: Questionnaire administration Other: Laboratory biomarker analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with diabetes mellitus type 2 treated with and without Metformin.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111967

Contacts
Contact: Philipp N Walter, Dr. 062 311 48 19 philipp.walter@unibas.ch
Contact: Corina Metaxas, MSc 061 267 15 19 corina.metaxas@unibas.ch

Locations
Switzerland
Pharmaceutical Care Research Group Recruiting
Basel, Switzerland, 4056
Contact: Philipp Walter, Dr.    062 311 48 19    philipp.walter@unibas.ch   
Contact: Corina Metaxas, Msc    061 267 15 19    corina.metaxas@unibas.ch   
Principal Investigator: Philipp N Walter, Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Solothurner Spitäler AG
Investigators
Study Chair: Kurt E Hersberger, Prof. Pharmaceutical Care Research Group
Principal Investigator: Philipp N Walter, Dr. Pharmaceutical Care Research Group
Study Director: Gottfried Rudofsky, Prof. Dr. Kantonsspital Olten
  More Information

No publications provided

Responsible Party: Philipp Walter, PhD, Dr., University of Basel
ClinicalTrials.gov Identifier: NCT02111967     History of Changes
Other Study ID Numbers: PCRG_Metformin_CMG
Study First Received: April 9, 2014
Last Updated: April 9, 2014
Health Authority: Switzerland: Laws and standards

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Vitamin B Complex
Vitamins
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Malnutrition
Nutrition Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 18, 2014