Diabetes Mellitus, Type 2VITANCT03447275
The Vitamin B Status in Type 2 Diabetes (VITA) Study
An observational study of Diabetes Mellitus, Type 2 and Vitamin B 12 Deficiency, run by Rima Obeid.
Trial summary
The objective of this study was to evaluate vitamin B deficiency (particularly vitamin B6 deficiency) in diabetic patients in Germany in relation to the presence or absence of proteinuria, and global vascular risk. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Vitamin B 12 Deficiency, Vitamin B 6 Deficiency
- What is being tested?
- Type 2 diabetes
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Sep 2011
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 122 patients with type 2 Diabetes and 52 control subjects were recruited (50% women in both groups).
Who may be able to join
- Written informed consent before any study-related activities
- Ambulatory subject >18 years of age
- For patients with type 2 Diabetes:
- Duration of diabetes ≥ 5 years
- Glycated haemoglobin (HbA1C) <10%
- Body mass index (BMI) 19-40 kg/m2
- For healthy controls:
- No diabetes (normal fasting glucose levels measured by stick)
Who cannot join
- End stage renal disease (creatinine clearance <10 mL/min)
- Severe excess alcohol consumption (>50 units/week)
- Severe co-morbidities
- Renal and/or pancreatic transplant
- Vitamin B1, B6 and/or B12 substitution (incl. multivitamin preparations)
- Participation in an interventional study within 30 previous days;
- Patient is female and pregnant or lactating
- Patient is female in a childbearing age without adequate contraceptive precaution
About this study
The objective of this study was to evaluate vitamin B deficiency (particularly vitamin B6 deficiency) in diabetic patients in Germany in relation to the presence or absence of proteinuria, and global vascular risk.
Read the detailed description
This observational study recruited either control subjects or patients with type 2 diabetes for over 5 years and collected information on cardiovascular risk factors. Fasting blood samples and urine were collected and biomarkers of B-vitamins were measured and were related to renal function or to global cardiovascular risk. Global cardiovascular risk was calculated from established models that include Routine clinical and laboratory markers such as plasma lipids, smoking, hypertension, and BMI.
we measured the following markers: Glucose (fasting plasma glucose); HbA1C; serum creatinine; Glomerular filtration rate (GFR), urinary Albumin, C-reactive Protein, Soluble vascular cell adhesion molecule 1 (sVCAM-1), cystatin C, vitamin B1, vitamin B12, holotranscobalamin, methylmalonic acid, homocysteine, and different vitamin B6 forms.
- Being tested
- Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Vitamin B 12 Deficiency, Vitamin B 6 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 2 diabetesOther
Test if patients with diabetes have different blood concentrations of vitamin biomarkers compared with control subjects and if vitamin levels in the patients will differ according to renal damage.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Apparently healthy subjects without type 2 diabetes Receives: Other: Type 2 diabetes | |
| Patients with type 2 diabetes | type 2 Diabetes since 5 years or longer Receives: Other: Type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in serum vitamin B12 levels between cases and controls
Compare mean levels of the controls with those in the patients
Measured: Baseline
The difference in serum vitamin B1 between cases and controls
Compare mean levels of the controls with those in the patients
Measured: Baseline
The difference in serum vitamin B6 concentrations between cases and controls
Compare mean levels of the controls with those in the patients
Measured: Baseline
Secondary outcomes (4)
The difference in serum vitamin B12 between patients with and those without albuminuria
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Measured: Baseline
The difference in serum and urine vitamin B1 between patients with and those without albuminuria
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Measured: Baseline
The difference in serum and urine vitamin B6 vitamers between patients with and those without albuminuria
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Measured: Baseline
The difference in serum and urine vitamin B6 vitamers between patients with advanced global vascular risk versus those with a low vascular risk
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rima Obeid
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, Syneed Medidata GmbH
- Responsible party
- Sponsor-investigator, Rima Obeid, Universität des Saarlandes
- Investigators
- Wilfred A Nix, PhD, Principal investigator, Department of Neurology, Medical University of Mainz, 55131 Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447275
- Sponsor's protocol ID
- EMR 200054-604
- Acronym
- VITA
- Status last verified
- May 2018
- First submitted
- 19 Feb 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be shared
Publications
Nix WA, Zirwes R, Bangert V, Kaiser RP, Schilling M, Hostalek U, Obeid R. Vitamin B status in patients with type 2 diabetes mellitus with and without incipient nephropathy. Diabetes Res Clin Pract. 2015 Jan;107(1):157-65. doi: 10.1016/j.diabres.2014.09.058. Epub 2014 Oct 8.
PubMed 25458341
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vitamin B Status in Type 2 Diabetes (VITA) Study
- ClinicalTrials.gov ID
- NCT03447275
- Acronym / sponsor ID
- VITA / EMR 200054-604
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Rima ObeidUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, Syneed Medidata GmbH
- Study start
- Jan 2011 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Feb 2018 (actual)
- 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.
The objective of this study was to evaluate vitamin B deficiency (particularly vitamin B6 deficiency) in diabetic patients in Germany in relation to the presence or absence of proteinuria, and global vascular risk.
Detailed description
This observational study recruited either control subjects or patients with type 2 diabetes for over 5 years and collected information on cardiovascular risk factors. Fasting blood samples and urine were collected and biomarkers of B-vitamins were measured and were related to renal function or to global cardiovascular risk. Global cardiovascular risk was calculated from established models that include Routine clinical and laboratory markers such as plasma lipids, smoking, hypertension, and BMI.
we measured the following markers: Glucose (fasting plasma glucose); HbA1C; serum creatinine; Glomerular filtration rate (GFR), urinary Albumin, C-reactive Protein, Soluble vascular cell adhesion molecule 1 (sVCAM-1), cystatin C, vitamin B1, vitamin B12, holotranscobalamin, methylmalonic acid, homocysteine, and different vitamin B6 forms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Other: Type 2 diabetesApparently healthy subjects without type 2 diabetes |
| Patients with type 2 diabetes | – | Other: Type 2 diabetestype 2 Diabetes since 5 years or longer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 122 patients with type 2 Diabetes and 52 control subjects were recruited (50% women in both groups).
Key inclusion criteria (8 listed)
- Written informed consent before any study-related activities
- Ambulatory subject >18 years of age
- Duration of diabetes ≥ 5 years
- Glycated haemoglobin (HbA1C) <10%
- Body mass index (BMI) 19-40 kg/m2
Key exclusion criteria (8 listed)
- End stage renal disease (creatinine clearance <10 mL/min)
- Severe excess alcohol consumption (>50 units/week)
- Severe co-morbidities
- Renal and/or pancreatic transplant
- Vitamin B1, B6 and/or B12 substitution (incl. multivitamin preparations)
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 |
|---|---|---|
| Type 2 diabetesTest if patients with diabetes have different blood concentrations of vitamin biomarkers compared with control subjects and if vitamin levels in the patients will differ according to renal damage. | Other | Controls, Patients with type 2 diabetes |
Primary outcome
The difference in serum vitamin B12 levels between cases and controls
Time frame: Baseline
Compare mean levels of the controls with those in the patients
The difference in serum vitamin B1 between cases and controls
Time frame: Baseline
Compare mean levels of the controls with those in the patients
The difference in serum vitamin B6 concentrations between cases and controls
Time frame: Baseline
Compare mean levels of the controls with those in the patients
4 secondary outcomes
The difference in serum vitamin B12 between patients with and those without albuminuria
Time frame: Baseline
The difference in serum and urine vitamin B1 between patients with and those without albuminuria
Time frame: Baseline
The difference in serum and urine vitamin B6 vitamers between patients with and those without albuminuria
Time frame: Baseline
The difference in serum and urine vitamin B6 vitamers between patients with advanced global vascular risk versus those with a low vascular risk
Time frame: Baseline
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 14 May 2018.
- Results publication: PubMed 25458341Nix WA, Zirwes R, Bangert V, Kaiser RP, Schilling M, Hostalek U, Obeid R. Vitamin B status in patients with type 2 diabetes mellitus with and without incipient nephropathy. Diabetes Res Clin Pract. 2015 Jan;107(1):157-65. doi: 10.1016/j.diabres.2014.09.058. Epub 2014 Oct 8.
- Journal WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. data will not be shared
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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.
Wilfred A Nix, PhD principal investigator
Department of Neurology, Medical University of Mainz, 55131 Mainz, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Vitamin B 12 Deficiency, run by Rima Obeid.
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 8 inclusion and 8 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 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The difference in serum vitamin B12 levels between cases and controls (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447275, which also lists 1 linked publication.
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 14 May 2018.