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Pioglitazone in Impaired Glucose Tolerance

This study has been withdrawn prior to enrollment.
(financial support withdrawn)
Sponsor:
Collaborator:
Institut für Gesundheits- und Praxismanagement GmbH
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00306826
First received: March 23, 2006
Last updated: February 1, 2010
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Praxis Antje Horn
Gera, Germany, 07548
Praxis Gunter Kässner
Leipzig, Germany, 04229
Praxis Heidrun Täschner
Leipzig, Germany, 04249
Praxis Martin Schönauer
Leipzig, Germany, 04275
Praxis Matthias Schreiner
Leipzig, Germany, 04357
Praxis Matthias Weissbrodt
Leipzig, Germany, 04299
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

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

Keywords provided by University of Leipzig:
Impaired glucose tolerance

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Pioglitazone
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014