Study Stopped
financial support withdrawn
Pioglitazone in Impaired Glucose Tolerance
Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance
1 other identifier
interventional
120
1 country
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 2, 2010
June 1, 2008
March 23, 2006
February 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in intima media thickness of carotid artery
Secondary Outcomes (3)
Heart rate variability
Flow-mediated dilatation of brachial artery
Vascular/metabolic lab parameters
Interventions
Eligibility Criteria
You may qualify if:
- Impaired glucose tolerance
- Age 40 to 75 years
You may not qualify if:
- 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 \[CAD\])
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Praxis Antje Horn
Gera, 07548, Germany
Praxis Gunter Kässner
Leipzig, 04229, Germany
Praxis Heidrun Täschner
Leipzig, 04249, Germany
Praxis Martin Schönauer
Leipzig, 04275, Germany
University of Leipzig Heart Center
Leipzig, 04289, Germany
Praxis Matthias Weissbrodt
Leipzig, 04299, Germany
Praxis Matthias Schreiner
Leipzig, 04357, Germany
Related Publications (1)
Ipsen EO, 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(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
PMID: 33210751DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gerhard Schuler, MD
University of Leipzig
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 23, 2006
First Posted
March 24, 2006
Study Completion
May 1, 2009
Last Updated
February 2, 2010
Record last verified: 2008-06