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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Vitamin B 12 Deficiency; Vitamin B 6 Deficiency
• Intervention / Treatment: Other: Type 2 diabetes

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 Type: Observational
• Enrollment (Actual): 174

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

122 patients with type 2 Diabetes and 52 control subjects were recruited (50% women in both groups).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls; Apparently healthy subjects without type 2 diabetes	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.
Patients with type 2 diabetes; type 2 Diabetes since 5 years or longer	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rima Obeid
• Collaborators: Merck KGaA, Darmstadt, Germany; Syneed Medidata GmbH
• Investigators: Principal Investigator: Wilfred A Nix, PhD, Department of Neurology, Medical University of Mainz, 55131 Mainz, Germany

Publications and helpful links

General 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.

Helpful Links

• Journal Website

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Vitamin B 12 Deficiency; Vitamin B 6 Deficiency
• Other Study ID Numbers: EMR 200054-604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No