Pioglitazone in Impaired Glucose Tolerance - Full Text View

Sponsor:	University of Leipzig
Collaborator:	Institut für Gesundheits- und Praxismanagement GmbH
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00306826

Purpose

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

Condition	Intervention	Phase
Glucose Metabolism Disorders	Drug: pioglitazone Drug: simvastatin Drug: pioglitazone + simvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Disorders

Drug Information available for: Dextrose Simvastatin Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

Change in intima media thickness of carotid artery

Secondary Outcome Measures:

Heart rate variability
Flow-mediated dilatation of brachial artery
Vascular/metabolic lab parameters

Estimated Enrollment:	120
Estimated Study Completion Date:	May 2009

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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])

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306826

Locations

Germany
Praxis Antje Horn
Gera, Germany, 07548
Praxis Matthias Schreiner
Leipzig, Germany, 04357
Praxis Martin Schönauer
Leipzig, Germany, 04275
Praxis Gunter Kässner
Leipzig, Germany, 04229
Praxis Matthias Weissbrodt
Leipzig, Germany, 04299
Praxis Heidrun Täschner
Leipzig, Germany, 04249
University of Leipzig Heart Center
Leipzig, Germany, 04289

Sponsors and Collaborators

University of Leipzig

Institut für Gesundheits- und Praxismanagement GmbH

Investigators

Study Chair:

Gerhard Schuler, MD

University of Leipzig

More Information

No publications provided

Study ID Numbers:	Leipzig-01
Study First Received:	March 23, 2006
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00306826 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

Impaired glucose tolerance

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Pioglitazone
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Glucose Intolerance
Physiological Effects of Drugs

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Hyperglycemia
Hypoglycemic Agents
Therapeutic Uses
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on March 18, 2010