NCT00523393

Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells

Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells in Patients With Type 2 Diabetes: a Partially Double-Blind, Randomized, Three-Arm Unicenter Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Insulin Glargin	Titration of bedtime insulin glargin aiming at normal morning fasting glucose
DRUG	Human Insulin	Titration of bedtime human insulin aiming at normal morning fasting glucose

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2007-08-31
• Last updated: 2009-02-13

Locations

1 site across 1 country: Germany