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

R

Rima Obeid

Status

Completed

Conditions

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

Treatments

Other: Type 2 diabetes

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03447275
EMR 200054-604

Details and patient eligibility

About

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.

Full 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.

Enrollment

174 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

174 participants in 2 patient groups

Controls
Description:
Apparently healthy subjects without type 2 diabetes
Treatment:
Other: Type 2 diabetes
Patients with type 2 diabetes
Description:
type 2 Diabetes since 5 years or longer
Treatment:
Other: Type 2 diabetes

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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