An interventional study of Pioglitazone and Glimepiride in Impaired Glucose Tolerance, Type 2 Diabetes Mellitus and Atherosclerosis, sponsored by Kurume University. Completed at 1 site in Japan. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-09-27.
Sponsored by Kurume University · Not applicable, Interventional, and Treatment
There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.
Atherosclerotic patients with impaired glucose tolerance and type 2 diabetes will undergo the FDG-PET/CT imaging at baseline and again following 4 months after treatment. Patients who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone or 4 mg/day glimepiride. Physical examinations will be done at baseline, 4 months, and 12 months. During study, subjects will have body weight, and vital signs (HR, BP, etc) assessed as well as waist circumference. Laboratory assessments will be done at each baseline, 4 month.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 70 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Kurume University is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
up to 30 mg pioglitazone, tablet, orally, once daily
Drug: Pioglitazone
up to 4 mg/day glimepiride, tablet, orally, once daily
Drug: Glimepiride
Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.
Also known as: CAS number: 111025-46-8, ATC code: A10BG03
Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.
Also known as: CAS number: 93479-97-1, ATC code: A10BB12
Effect of treatment on the nominal change in FDG uptake of atherosclerotic plaque from baseline after 4 months of treatment as measured by FDG-PET/CT imaging.
Time frame: Baseline and 4 months after treatment
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating markers of atherosclerosis
Time frame: Baseline and 4 months and 5 years after treatment
Change from baseline in visceral fat
Time frame: Baseline and 4 months and 5 years after treatment
All cardiovascular events and all cause death for 5 years
Time frame: Baseline and 4 months and 5 years after treatment
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Kurume University