Anti-Inflammatory Effects of Pioglitazone
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ClinicalTrials.gov Identifier: NCT00722631 |
Recruitment Status
:
Completed
First Posted
: July 25, 2008
Last Update Posted
: September 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Impaired Glucose Tolerance Type 2 Diabetes Mellitus Atherosclerosis | Drug: Pioglitazone Drug: Glimepiride | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
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 |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
up to 30 mg pioglitazone, tablet, orally, once daily
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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
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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
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 35 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Kurume University Hospital | |
Kurume city, Japan, 830-0011 |
Principal Investigator: | Nobuhiro Tahara, MD, PhD | Kurume University |
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 Posted: | July 25, 2008 Key Record Dates |
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 |