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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | up to 30 mg pioglitazone, tablet, orally, once daily |
|
| 2 | Active Comparator | up to 4 mg/day glimepiride, tablet, orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nobuhiro Tahara, MD, PhD | Kurume University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurume University Hospital | Kurume | 830-0011 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33210751 | Derived | 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. | |
| 31407236 |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Glimepiride | Drug | Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride. |
|
|
| All cardiovascular events and all cause death for 5 years | Baseline and 4 months and 5 years after treatment |
| 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. Two-hour postload plasma glucose and pigment epithelium-derived factor levels are markers of coronary artery inflammation in type 2 diabetic patients. J Nucl Cardiol. 2020 Aug;27(4):1352-1364. doi: 10.1007/s12350-019-01842-5. Epub 2019 Aug 12. |
| 24229770 | Derived | Nitta Y, Tahara N, Tahara A, Honda A, Kodama N, Mizoguchi M, Kaida H, Ishibashi M, Hayabuchi N, Ikeda H, Yamagishi S, Imaizumi T. Pioglitazone decreases coronary artery inflammation in impaired glucose tolerance and diabetes mellitus: evaluation by FDG-PET/CT imaging. JACC Cardiovasc Imaging. 2013 Nov;6(11):1172-82. doi: 10.1016/j.jcmg.2013.09.004. |
| 24030946 | Derived | Kodama N, Tahara N, Tahara A, Honda A, Nitta Y, Mizoguchi M, Kaida H, Ishibashi M, Abe T, Ikeda H, Narula J, Fukumoto Y, Yamagishi S, Imaizumi T. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Nov;98(11):4438-45. doi: 10.1210/jc.2013-2920. Epub 2013 Sep 12. |
| 21999871 | Derived | 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. 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. JACC Cardiovasc Imaging. 2011 Oct;4(10):1110-8. doi: 10.1016/j.jcmg.2011.08.007. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |