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

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.

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