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

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ClinicalTrials.gov Identifier: NCT03447275
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
Merck KGaA
Syneed Medidata GmbH
Information provided by (Responsible Party):
Rima Obeid, Saarland University

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Vitamin B 12 Deficiency Vitamin B 6 Deficiency 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
Actual Enrollment : 174 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Vitamin B Status in Type 2 Diabetes (VITA) Study
Actual Study Start Date : January 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

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.




Primary Outcome Measures :
  1. The difference in serum vitamin B12 levels between cases and controls [ Time Frame: Baseline ]
    Compare mean levels of the controls with those in the patients

  2. The difference in serum vitamin B1 between cases and controls [ Time Frame: Baseline ]
    Compare mean levels of the controls with those in the patients

  3. The difference in serum vitamin B6 concentrations between cases and controls [ Time Frame: Baseline ]
    Compare mean levels of the controls with those in the patients


Secondary Outcome Measures :
  1. The difference in serum vitamin B12 between patients with and those without albuminuria [ Time Frame: Baseline ]
    Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria

  2. The difference in serum and urine vitamin B1 between patients with and those without albuminuria [ Time Frame: Baseline ]
    Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria

  3. The difference in serum and urine vitamin B6 vitamers between patients with and those without albuminuria [ Time Frame: Baseline ]
    Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria

  4. The difference in serum and urine vitamin B6 vitamers between patients with advanced global vascular risk versus those with a low vascular risk [ Time Frame: Baseline ]
    Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
122 patients with type 2 Diabetes and 52 control subjects were recruited (50% women in both groups).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447275


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

Additional Information:
Publications of Results:
Responsible Party: Rima Obeid, Prof. Dr., Saarland University
ClinicalTrials.gov Identifier: NCT03447275     History of Changes
Other Study ID Numbers: EMR 200054-604
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin B 12 Deficiency
Vitamin B 6 Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs