Diabetes Mellitus Type 2NCT02111967
Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin
An observational study of Diabetes Mellitus Type 2, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Questionnaire administration and Laboratory biomarker analysis
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes mellitus type 2 treated with and without Metformin.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement
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
- Being tested
- Questionnaire administration, Laboratory biomarker analysis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
Laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus type 2, Metformin | The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin. Receives: 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 Receives: Other: Questionnaire administration; Other: Laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of serum vitamin B12 and serum holotranscobalamin concentrations
VB12, HoloTc
Measured: day 3
Secondary outcomes (1)
Questionnaire results
Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM.
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Solothurner Spitäler AG
- Responsible party
- Principal investigator, Philipp Walter, PhD, University of Basel
- Investigators
- Kurt E Hersberger, Prof., Study chair, Pharmaceutical Care Research GroupPhilipp N Walter, Dr., Principal investigator, Pharmaceutical Care Research GroupGottfried Rudofsky, Prof. Dr., Study director, Kantonsspital Olten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111967
- Sponsor's protocol ID
- PCRG_Metformin_CMG
- Status last verified
- Aug 2015
- First submitted
- 9 Apr 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement
- ClinicalTrials.gov ID
- NCT02111967
- Acronym / sponsor ID
- PCRG_Metformin_CMG
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Solothurner Spitäler AG
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus type 2, Metformin | – | Other: Questionnaire administration, Other: Laboratory biomarker analysisThe case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin. |
| Diabetes mellitus type 2 | – | Other: Questionnaire administration, Other: Laboratory biomarker analysisThe control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes mellitus type 2 treated with and without Metformin.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Measurements of serum vitamin B12 and serum holotranscobalamin concentrations
Time frame: day 3
VB12, HoloTc
1 secondary outcome
Questionnaire results
Time frame: day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E Hersberger, Prof. study chair
Pharmaceutical Care Research Group
Philipp N Walter, Dr. principal investigator
Pharmaceutical Care Research Group
Gottfried Rudofsky, Prof. Dr. study director
Kantonsspital Olten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of serum vitamin B12 and serum holotranscobalamin concentrations (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.