Pioglitazone in Impaired Glucose Tolerance

February 1, 2010 updated by: University of Leipzig

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

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

Study Overview

Status

Withdrawn

Conditions

Glucose Metabolism Disorders

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

120

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in intima media thickness of carotid artery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Institut für Gesundheits- und Praxismanagement GmbH

Investigators

Study Chair: Gerhard Schuler, MD, University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ipsen EØ, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11:CD013516. doi: 10.1002/14651858.CD013516.pub2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

May 1, 2009

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Impaired glucose tolerance

Additional Relevant MeSH Terms

Other Study ID Numbers

Leipzig-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.