Clinical trial NCT00306826: Pioglitazone in Impaired Glucose Tolerance
Official title: Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Glucose Metabolism Disorders
Keywords: Impaired glucose tolerance
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Institut für Gesundheits- und Praxismanagement GmbH
First posted: 2006-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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 \[CAD\])

Primary outcomes:
measure: Change in intima media thickness of carotid artery
Secondary outcomes:
measure: Heart rate variability
measure: Flow-mediated dilatation of brachial artery
measure: Vascular/metabolic lab parameters
Other outcomes:
Locations:
city: Gera
country: Germany
facility: Praxis Antje Horn
city: Leipzig
country: Germany
facility: Praxis Gunter Kässner
city: Leipzig
country: Germany
facility: Praxis Heidrun Täschner
city: Leipzig
country: Germany
facility: Praxis Martin Schönauer
city: Leipzig
country: Germany
facility: University of Leipzig Heart Center
city: Leipzig
country: Germany
facility: Praxis Matthias Weissbrodt
city: Leipzig
country: Germany
facility: Praxis Matthias Schreiner
Study officials:
affiliation: University of Leipzig
name: Gerhard Schuler, MD
role: STUDY_CHAIR
References:
citation: 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.