Pioglitazone in Impaired Glucose Tolerance

Study Overview
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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

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.

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

Conditions
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Glucose Metabolism Disorders

Intervention / Treatment
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* Drug: pioglitazone
* Drug: simvastatin
* Drug: pioglitazone + simvastatin


Participation Criteria
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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])

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pioglitazone|nan|
|Drug: simvastatin|nan|
|Drug: pioglitazone + simvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intima media thickness of carotid artery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  |  | 
| Flow-mediated dilatation of brachial artery |  |  | 
| Vascular/metabolic lab parameters |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired glucose tolerance