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Anti-Inflammatory Effects of Pioglitazone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722631
First Posted: July 25, 2008
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nobuhiro Tahara, Kurume University
  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
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

Resource links provided by NLM:


Further study details as provided by Nobuhiro Tahara, 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 ]

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 ]

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

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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):
Responsible Party: Nobuhiro Tahara, M.D., PhD, Kurume University
ClinicalTrials.gov Identifier: NCT00722631     History of Changes
Other Study ID Numbers: PIO 2007
First Submitted: July 22, 2008
First Posted: July 25, 2008
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