Pioglitazone in Impaired Glucose Tolerance

University of Leipzig

Status and phase

Withdrawn

Phase 4

Conditions

Glucose Metabolism Disorders

Treatments

Drug: simvastatin

Drug: pioglitazone

Drug: pioglitazone + simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00306826

Leipzig-01

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Impaired glucose tolerance
Age 40 to 75 years

Exclusion criteria

Diabetes mellitus type 1 or 2
Hypersensitivity to study medication
Malignant tumor
Alcohol or drug abuse
Overt heart failure
Severe hepatic, renal, neurological, psychiatric, or hematological disease
Prior treatment with glitazones or statins
Established indication for statin treatment (e.g. coronary artery disease [CAD])