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

July 22, 2008
September 26, 2012
May 2007
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00722631 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Anti-Inflammatory Effects of Pioglitazone
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Impaired Glucose Tolerance
  • Type 2 Diabetes Mellitus
  • Atherosclerosis
  • 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
  • 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
  • Experimental: 1
    up to 30 mg pioglitazone, tablet, orally, once daily
    Intervention: Drug: Pioglitazone
  • Active Comparator: 2
    up to 4 mg/day glimepiride, tablet, orally, once daily
    Intervention: Drug: Glimepiride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2012
April 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00722631
PIO 2007
Yes
Nobuhiro Tahara, Kurume University
Kurume University
Not Provided
Principal Investigator: Nobuhiro Tahara, MD, PhD Kurume University
Kurume University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP