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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.
Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.
Kurume University Hospital
Kurume, Japan
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
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