Clinical trial NCT03447275: The Vitamin B Status in Type 2 Diabetes (VITA) Study
Official title: The Vitamin B Status in Type 2 Diabetes (VITA) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Vitamin B 12 Deficiency
Vitamin B 6 Deficiency
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Merck KGaA, Darmstadt, Germany
name: Syneed Medidata GmbH
First posted: 2018-02-27
Enrollment: 174
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 122 patients with type 2 Diabetes and 52 control subjects were recruited (50% women in both groups).

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent before any study-related activities
2. Ambulatory subject \>18 years of age

   For patients with type 2 Diabetes:
3. Duration of diabetes ≥ 5 years
4. Glycated haemoglobin (HbA1C) \<10%
5. Body mass index (BMI) 19-40 kg/m2

   For healthy controls:
6. No diabetes (normal fasting glucose levels measured by stick)

Exclusion Criteria:

1. End stage renal disease (creatinine clearance \<10 mL/min)
2. Severe excess alcohol consumption (\>50 units/week)
3. Severe co-morbidities
4. Renal and/or pancreatic transplant
5. Vitamin B1, B6 and/or B12 substitution (incl. multivitamin preparations)
6. Participation in an interventional study within 30 previous days;
7. Patient is female and pregnant or lactating
8. Patient is female in a childbearing age without adequate contraceptive precaution

Primary outcomes:
measure: The difference in serum vitamin B12 levels between cases and controls
timeFrame: Baseline
measure: The difference in serum vitamin B1 between cases and controls
timeFrame: Baseline
measure: The difference in serum vitamin B6 concentrations between cases and controls
timeFrame: Baseline
Secondary outcomes:
measure: The difference in serum vitamin B12 between patients with and those without albuminuria
timeFrame: Baseline
measure: The difference in serum and urine vitamin B1 between patients with and those without albuminuria
timeFrame: Baseline
measure: The difference in serum and urine vitamin B6 vitamers between patients with and those without albuminuria
timeFrame: Baseline
measure: The difference in serum and urine vitamin B6 vitamers between patients with advanced global vascular risk versus those with a low vascular risk
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurology, Medical University of Mainz, 55131 Mainz, Germany
name: Wilfred A Nix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.