Anti-Inflammatory Effects of Pioglitazone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobuhiro Tahara, Kurume University
ClinicalTrials.gov Identifier:
NCT00722631
First received: July 22, 2008
Last updated: September 26, 2012
Last verified: September 2012
  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:


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
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

No publications provided by Kurume University

Additional 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
Study First Received: July 22, 2008
Last Updated: September 26, 2012
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 July 28, 2014