Pioglitazone in Impaired Glucose Tolerance

• Status: Withdrawn
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leipzig
• Collaborator: Institut für Gesundheits- und Praxismanagement GmbH
• Treatments: Pioglitazone; Simvastatin

Criteria

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])