In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
75
Titration of bedtime insulin glargin aiming at normal morning fasting glucose
Titration of bedtime human insulin aiming at normal morning fasting glucose
University Clinics Heidelberg, Dept. Medicine1
Heidelberg, Germany
RECRUITINGChange of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis
Time frame: 4 weaks of treatment
Change of number of circulating EPC 4 as detected by in vitro outgrowth
Time frame: 4 weeks, 4 months
Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)
Time frame: 4 months
Myocardial function and myocardial perfusion reserve as measured by MRI
Time frame: 4 months
Intima-Media-Thickness
Time frame: 4 months
Long-term Glucose control (HbA1c)
Time frame: 4 weeks, 4 months
Short-term Glucose control (fasting glucose)
Time frame: 4 weeks, 4 months
Markers of inflammation and vascular risk in diabetes
Time frame: 4 weeks, 4 months
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