Pioglitazone in Impaired Glucose Tolerance

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00306826
• Other study ID #: Leipzig-01
• Status: Withdrawn
• Phase: Phase 4
• First received: March 23, 2006
• Last updated: February 1, 2010
• Est. completion date: May 2009

Study information

• Verified date: June 2008
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 120
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• pioglitazone

• simvastatin

• pioglitazone + simvastatin

Locations

Country	Name	City	State
Germany	Praxis Antje Horn	Gera
Germany	Praxis Gunter Kässner	Leipzig
Germany	Praxis Heidrun Täschner	Leipzig
Germany	Praxis Martin Schönauer	Leipzig
Germany	Praxis Matthias Schreiner	Leipzig
Germany	Praxis Matthias Weissbrodt	Leipzig
Germany	University of Leipzig Heart Center	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Institut für Gesundheits- und Praxismanagement GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intima media thickness of carotid artery
Secondary	Heart rate variability
Secondary	Flow-mediated dilatation of brachial artery
Secondary	Vascular/metabolic lab parameters