The Vitamin B Status in Type 2 Diabetes (VITA) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Vitamin B Status in Type 2 Diabetes (VITA) Study

Conditions
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Diabetes Mellitus, Type 2, Vitamin B 12 Deficiency, Vitamin B 6 Deficiency

Intervention / Treatment
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* Other: Type 2 diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Apparently healthy subjects without type 2 diabetes | Other: Type 2 diabetes<br>* 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.<br>|
| Patients with type 2 diabetes<br>type 2 Diabetes since 5 years or longer | Other: Type 2 diabetes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in serum vitamin B12 levels between cases and controls | Compare mean levels of the controls with those in the patients | Baseline | 
| The difference in serum vitamin B1 between cases and controls | Compare mean levels of the controls with those in the patients | Baseline | 
| The difference in serum vitamin B6 concentrations between cases and controls | Compare mean levels of the controls with those in the patients | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Baseline |