Pioglitazone in Impaired Glucose Tolerance

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00306826

Enrollment

120

Registered

2006-03-24

Start date

Unknown

Completion date

2009-05-31

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism Disorders

Keywords

Impaired glucose tolerance

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.

Interventions

DRUGpioglitazone

DRUGsimvastatin

DRUGpioglitazone + simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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 \[CAD\])

Design outcomes

Primary

Measure	Time frame
Change in intima media thickness of carotid artery	—

Secondary

Measure	Time frame
Heart rate variability	—
Flow-mediated dilatation of brachial artery	—
Vascular/metabolic lab parameters	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026