NCT03447275

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 174 (actual)
• Sponsor: Rima Obeid · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Type 2 diabetes	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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2018-02-27
• Last updated: 2018-05-14