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
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 April 22, 2014