In patients with impaired glucose tolerance (IGT), the researchers want to study the relative effects of pioglitazone, simvastatin, or the combination of both on: * intima media thickness (IMT) as an easily assessed marker of atherosclerosis * heart rate variability (HRV) as a marker of autonomic neuropathy * flow-mediated vasodilatation (FMD) of the brachial artery as a marker of endothelial function * vascular and metabolic lab parameters
We want to study the relative effects of pioglitazone, simvastatin or the combination of both on intima media thickness (IMT), heart rate variability (HRV), flow-mediated vasodilatation (FMD) of the brachial artery and vascular/metabolic lab parameters in patients with impaired glucose tolerance (IGT). Previous studies have shown a reduction in IMT for both pioglitazone and simvastatin in type 2 diabetics. Many patients with diabetes mellitus develop diabetic polyneuropathy which can be assessed by measuring HRV. It has been shown that pioglitazone has a positive effect on HRV in type 2 diabetics. Questions remain on the relative efficacy of pioglitazone and simvastatin on the parameters mentioned above. Also, there is only scarce data in patients with IGT (as opposed to overt diabetes mellitus). There are no data on the relative effects of pioglitazone and simvastatin on flow-mediated vasodilatation (FMD) of the brachial artery as a surrogate marker for endothelial function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Praxis Antje Horn
Gera, Germany
Praxis Gunter Kässner
Leipzig, Germany
Praxis Heidrun Täschner
Leipzig, Germany
Praxis Martin Schönauer
Leipzig, Germany
Change in intima media thickness of carotid artery
Heart rate variability
Flow-mediated dilatation of brachial artery
Vascular/metabolic lab parameters
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Leipzig Heart Center
Leipzig, Germany
Praxis Matthias Weissbrodt
Leipzig, Germany
Praxis Matthias Schreiner
Leipzig, Germany