Anti-Inflammatory Effects of Pioglitazone

Conditions

Atherosclerosis, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus

Brief summary

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.

Detailed description

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.

Tahara N, Nitta Y, Bekki M, Tahara A, Maeda-Ogata S, Sugiyama Y, Honda A, Igata S, Nakamura T, Sun J, Kurata S, Fujimoto K, Abe T, Matsui T, Yamagishi SI, Fukumoto Y.

2019-08-123 citations

10.1007/s12350-019-01842-5

Pioglitazone decreases coronary artery inflammation in impaired glucose tolerance and diabetes mellitus: evaluation by FDG-PET/CT imaging.

Nitta Y, Tahara N, Tahara A, Honda A, Kodama N, Mizoguchi M, Kaida H, Ishibashi M, Hayabuchi N, Ikeda H, Yamagishi S, Imaizumi T.

2013-11-0142 citations

10.1016/j.jcmg.2013.09.004

Pioglitazone attenuates atherosclerotic plaque inflammation in patients with impaired glucose tolerance or diabetes a prospective, randomized, comparator-controlled study using serial FDG PET/CT imaging study of carotid artery and ascending aorta.

Mizoguchi M, Tahara N, Tahara A, Nitta Y, Kodama N, Oba T, Mawatari K, Yasukawa H, Kaida H, Ishibashi M, Hayabuchi N, Harada H, Ikeda H, Yamagishi S, Imaizumi T.

2011-10-0193 citations

10.1016/j.jcmg.2011.08.007

Interventions

DRUGPioglitazone

Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.

DRUGGlimepiride

Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

* Subjects between the ages of 35 and 85 years * Subjects with impaired glucose tolerance and type 2 diabetes, who had atherosclerosis detected by carotid ultrasound and/or CT * Subjects who had vascular FDG uptake by FDG-PET

Exclusion criteria

* Subjects with insulin treatment * Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease * Subjects taking more than three antidiabetic medications * Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones (TZDs) within 8 weeks prior to randomization * Subjects with cardiac failure (New York Heart Association Class \> III) or left ventricular dysfunction (LVEF \< 40%) * Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease

Design outcomes

Primary

Measure	Time frame
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.	Baseline and 4 months after treatment

Secondary

Measure	Time frame
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating markers of atherosclerosis	Baseline and 4 months and 5 years after treatment
Change from baseline in visceral fat	Baseline and 4 months and 5 years after treatment
All cardiovascular events and all cause death for 5 years	Baseline and 4 months and 5 years after treatment

Countries

Japan

Outcome results

None listed