Anti-Inflammatory Effects of Pioglitazone - Full Text View

Sponsor:	Kurume University
Information provided by:	Kurume University
ClinicalTrials.gov Identifier:	NCT00722631

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Atherosclerosis Diabetes Diabetes Medicines Diabetes Type 2

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 ]

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722631

Contacts

Contact: Nobuhiro Tahara, MD, PhD	+81-942-31-7580	ntahara@med.kurume-u.ac.jp
Contact: Minori Mizoguchi, MD	+81-942-31-7562

Locations

Japan
Kurume University Hospital	Recruiting
Kurume city, Japan, 830-0011
Contact: Nobuhiro Tahara, MD, PhD +81-942-31-7580 ntahara@med.kurume-u.ac.jp
Contact: Minori Mizoguchi, MD +81-942-31-7562
Principal Investigator: Nobuhiro Tahara, MD, PhD

Sponsors and Collaborators

Kurume University

Investigators

Principal Investigator:

Nobuhiro Tahara, MD, PhD

Kurume University

More Information

No publications provided by Kurume University

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

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.

Responsible Party:	Department of Medicine, Division of Cardio-Vascular Medicine, Kurume University School of Medicine
ClinicalTrials.gov Identifier:	NCT00722631 History of Changes
Other Study ID Numbers:	PIO 2007
Study First Received:	July 22, 2008
Last Updated:	September 16, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

Anti-Inflammatory Agents
Glimepiride
Pioglitazone
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012