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Completed

NCT Number: NCT00722631

Anti-Inflammatory Effects of Pioglitazone

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.

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Key information

Conditions

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

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurume University Hospital

Kurume, 830-0011, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.

Other names: CAS number: 111025-46-8, ATC code: A10BG03

Glimepiride

Drug

Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.

Other names: CAS number: 93479-97-1, ATC code: A10BB12

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change from baseline in visceral fat

    Time frame: Baseline and 4 months and 5 years after treatment

  3. All cardiovascular events and all cause death for 5 years

    Time frame: Baseline and 4 months and 5 years after treatment

Sponsors and collaborators

Lead sponsor

Kurume University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Jul 25, 2008
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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