Pioglitazone in Impaired Glucose Tolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2009-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pioglitazone

Intervention Type DRUG

simvastatin

Intervention Type DRUG

pioglitazone + simvastatin

Intervention Type DRUG

Eligibility Criteria

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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 \[CAD\])

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No