NCT00306826

Pioglitazone in Impaired Glucose Tolerance

Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Glucose Metabolism Disorders

Interventions

Type	Name	Description
DRUG	pioglitazone
DRUG	simvastatin
DRUG	pioglitazone + simvastatin

Timeline

• Completion: 2009-05-01
• First posted: 2006-03-24
• Last updated: 2010-02-02

Locations

7 sites across 1 country: Germany