Pioglitazone in Impaired Glucose Tolerance

Phase 4

Withdrawn

• Conditions: Glucose Metabolism Disorders

• Registration Number: NCT00306826
• Lead Sponsor: University of Leipzig

Brief 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.

Study Timeline

• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-24
• Status Verified: 2008-06
• Study Completion: 2009-05
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 120

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])

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in intima media thickness of carotid artery

Secondary Outcome Measures

Name	Time	Method
Heart rate variability
Flow-mediated dilatation of brachial artery
Vascular/metabolic lab parameters

Trial Locations

Locations (7)

Praxis Gunter Kässner; 🇩🇪 Leipzig, Germany

Praxis Matthias Weissbrodt; 🇩🇪 Leipzig, Germany

Praxis Matthias Schreiner; 🇩🇪 Leipzig, Germany

Praxis Heidrun Täschner; 🇩🇪 Leipzig, Germany

University of Leipzig Heart Center; 🇩🇪 Leipzig, Germany

Praxis Antje Horn; 🇩🇪 Gera, Germany

Praxis Martin Schönauer; 🇩🇪 Leipzig, Germany