Anti-Inflammatory Effects of Pioglitazone

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ClinicalTrials.gov Identifier: NCT00722631

Recruitment Status : Completed

First Posted : July 25, 2008

Last Update Posted : September 27, 2012

Sponsor:

Information provided by (Responsible Party):

Nobuhiro Tahara, Kurume University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Impaired Glucose Tolerance Type 2 Diabetes Mellitus Atherosclerosis	Drug: Pioglitazone Drug: Glimepiride	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Detection of Plaque Inflammation and Visualization of Anti-Inflammatory Effects of Pioglitazone on Plaque Inflammation in Subjects With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus by FDG-PET/CT
Study Start Date :	May 2007
Actual Primary Completion Date :	April 2009
Actual Study Completion Date :	April 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

Drug Information available for: Glimepiride Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 up to 30 mg pioglitazone, tablet, orally, once daily	Drug: Pioglitazone Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone. Other Name: CAS number: 111025-46-8, ATC code: A10BG03
Active Comparator: 2 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 4 mg/day glimepiride. Other Name: CAS number: 93479-97-1, ATC code: A10BB12

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	35 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722631

Locations


Japan
Kurume University Hospital
Kurume city, Japan, 830-0011

Sponsors and Collaborators

Kurume University

Investigators


Principal Investigator:	Nobuhiro Tahara, MD, PhD	Kurume University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.


Responsible Party:	Nobuhiro Tahara, M.D., PhD, Kurume University
ClinicalTrials.gov Identifier:	NCT00722631 History of Changes
Other Study ID Numbers:	PIO 2007
First Posted:	July 25, 2008 Key Record Dates
Last Update Posted:	September 27, 2012
Last Verified:	September 2012

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Atherosclerosis Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases	Cardiovascular Diseases Hyperglycemia Pioglitazone Glimepiride Anti-Inflammatory Agents Hypoglycemic Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors

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