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

Diabetes Mellitus, Type 2 Clinical Trial

— VITA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447275
• Other study ID #: EMR 200054-604
• Status: Completed
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2018
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rima Obeid	Merck KGaA, Syneed Medidata GmbH

References & Publications (1)

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.2014.09.05 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in serum vitamin B12 levels between cases and controls	Compare mean levels of the controls with those in the patients	Baseline
Primary	The difference in serum vitamin B1 between cases and controls	Compare mean levels of the controls with those in the patients	Baseline
Primary	The difference in serum vitamin B6 concentrations between cases and controls	Compare mean levels of the controls with those in the patients	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Journal Website