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

NCT02111967 | Completed DMC

• 1 other identifier: PCRG_Metformin_CMG
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Measurements of serum vitamin B12 and serum holotranscobalamin concentrations

  VB12, HoloTc

  day 3

Secondary Outcomes (1)

• Questionnaire results

  day 8

Study Arms (2)

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

Interventions

Questionnaire administration OTHER

Diabetes mellitus type 2; Diabetes mellitus type 2, Metformin

Laboratory biomarker analysis OTHER

Diabetes mellitus type 2; Diabetes mellitus type 2, Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator
• Solothurner Spitäler AG: collaborator

Study Sites (1)

Pharmaceutical Care Research Group

Basel, Basel, 4056, Switzerland

Location

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kurt E Hersberger, Prof.

  Pharmaceutical Care Research Group

  STUDY CHAIR

• Philipp N Walter, Dr.

  Pharmaceutical Care Research Group

  PRINCIPAL INVESTIGATOR

• Gottfried Rudofsky, Prof. Dr.

  Kantonsspital Olten

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

CH (1)