Anti-Inflammatory Effects of Pioglitazone - Full Text View

Purpose

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	Intervention
Impaired Glucose Tolerance Type 2 Diabetes Mellitus Atherosclerosis	Drug: Pioglitazone Drug: Glimepiride


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Glimepiride Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Kurume University:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
Change from baseline in visceral fat [ Time Frame: Baseline and 4 months and 5 years after treatment ] [ Designated as safety issue: Yes ]
All cardiovascular events and all cause death for 5 years [ Time Frame: Baseline and 4 months and 5 years after treatment ] [ Designated as safety issue: Yes ]


Enrollment:	70
Study Start Date:	May 2007
Study Completion Date:	April 2012
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	35 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	July 22, 2008
Last Updated:	September 26, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 30, 2016