Status:
COMPLETED
The Vitamin B Status in Type 2 Diabetes (VITA) Study
Lead Sponsor:
Rima Obeid
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Syneed Medidata GmbH
Conditions:
Diabetes Mellitus, Type 2
Vitamin B 12 Deficiency
Eligibility:
All Genders
40+ years
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 ...
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 w...
Eligibility Criteria
Inclusion
- Written informed consent before any study-related activities
- Ambulatory subject \>18 years of age
- For patients with type 2 Diabetes:
- Duration of diabetes ≥ 5 years
- Glycated haemoglobin (HbA1C) \<10%
- Body mass index (BMI) 19-40 kg/m2
- For healthy controls:
- No diabetes (normal fasting glucose levels measured by stick)
Exclusion
- End stage renal disease (creatinine clearance \<10 mL/min)
- Severe excess alcohol consumption (\>50 units/week)
- Severe co-morbidities
- Renal and/or pancreatic transplant
- Vitamin B1, B6 and/or B12 substitution (incl. multivitamin preparations)
- Participation in an interventional study within 30 previous days;
- Patient is female and pregnant or lactating
- Patient is female in a childbearing age without adequate contraceptive precaution
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03447275
Start Date
January 1 2011
End Date
September 1 2011
Last Update
May 14 2018
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