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

Condition(s) targeted: Glucose Metabolism Disorders

Intervention: pioglitazone (Drug); simvastatin (Drug); pioglitazone + simvastatin (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: University of Leipzig

Official(s) and/or principal investigator(s):
Gerhard Schuler, MD, Study Chair, Affiliation: University of Leipzig

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in intima media thickness of carotid artery

Secondary outcome:

Heart rate variability

Flow-mediated dilatation of brachial artery

Vascular/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.

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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])

University of Leipzig Heart Center, Leipzig 04289, Germany

Praxis Matthias Schreiner, Leipzig 04357, Germany

Praxis Martin Schönauer, Leipzig 04275, Germany

Praxis Gunter Kässner, Leipzig 04229, Germany

Praxis Matthias Weissbrodt, Leipzig 04299, Germany

Praxis Heidrun Täschner, Leipzig 04249, Germany

Praxis Antje Horn, Gera 07548, Germany

Ending date: May 2009
Last updated: April 18, 2007