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Anti-Inflammatory Effects of Pioglitazone

Primary Purpose

Impaired Glucose Tolerance, Type 2 Diabetes Mellitus, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pioglitazone
Glimepiride
Sponsored by
Kurume University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kurume University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

up to 30 mg pioglitazone, tablet, orally, once daily

up to 4 mg/day glimepiride, tablet, orally, once daily

Outcomes

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.

Secondary Outcome Measures

Change from baseline in plasma glucose/insulin homeostatic parameters and circulating markers of atherosclerosis
Change from baseline in visceral fat
All cardiovascular events and all cause death for 5 years

Full Information

First Posted
July 22, 2008
Last Updated
September 26, 2012
Sponsor
Kurume University
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1. Study Identification

Unique Protocol Identification Number
NCT00722631
Brief Title
Anti-Inflammatory Effects of Pioglitazone
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kurume University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Type 2 Diabetes Mellitus, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
up to 30 mg pioglitazone, tablet, orally, once daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
up to 4 mg/day glimepiride, tablet, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
CAS number: 111025-46-8, ATC code: A10BG03
Intervention Description
Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Other Intervention Name(s)
CAS number: 93479-97-1, ATC code: A10BB12
Intervention Description
Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Change from baseline in visceral fat
Time Frame
Baseline and 4 months and 5 years after treatment
Title
All cardiovascular events and all cause death for 5 years
Time Frame
Baseline and 4 months and 5 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Tahara, MD, PhD
Organizational Affiliation
Kurume University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kurume University Hospital
City
Kurume city
ZIP/Postal Code
830-0011
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33210751
Citation
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
Results Reference
derived
PubMed Identifier
31407236
Citation
Tahara N, Nitta Y, Bekki M, Tahara A, Maeda-Ogata S, Sugiyama Y, Honda A, Igata S, Nakamura T, Sun J, Kurata S, Fujimoto K, Abe T, Matsui T, Yamagishi SI, Fukumoto Y. Two-hour postload plasma glucose and pigment epithelium-derived factor levels are markers of coronary artery inflammation in type 2 diabetic patients. J Nucl Cardiol. 2020 Aug;27(4):1352-1364. doi: 10.1007/s12350-019-01842-5. Epub 2019 Aug 12.
Results Reference
derived
PubMed Identifier
24229770
Citation
Nitta Y, Tahara N, Tahara A, Honda A, Kodama N, Mizoguchi M, Kaida H, Ishibashi M, Hayabuchi N, Ikeda H, Yamagishi S, Imaizumi T. Pioglitazone decreases coronary artery inflammation in impaired glucose tolerance and diabetes mellitus: evaluation by FDG-PET/CT imaging. JACC Cardiovasc Imaging. 2013 Nov;6(11):1172-82. doi: 10.1016/j.jcmg.2013.09.004.
Results Reference
derived
PubMed Identifier
24030946
Citation
Kodama N, Tahara N, Tahara A, Honda A, Nitta Y, Mizoguchi M, Kaida H, Ishibashi M, Abe T, Ikeda H, Narula J, Fukumoto Y, Yamagishi S, Imaizumi T. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Nov;98(11):4438-45. doi: 10.1210/jc.2013-2920. Epub 2013 Sep 12.
Results Reference
derived
PubMed Identifier
21999871
Citation
Mizoguchi M, Tahara N, Tahara A, Nitta Y, Kodama N, Oba T, Mawatari K, Yasukawa H, Kaida H, Ishibashi M, Hayabuchi N, Harada H, Ikeda H, Yamagishi S, Imaizumi T. Pioglitazone attenuates atherosclerotic plaque inflammation in patients with impaired glucose tolerance or diabetes a prospective, randomized, comparator-controlled study using serial FDG PET/CT imaging study of carotid artery and ascending aorta. JACC Cardiovasc Imaging. 2011 Oct;4(10):1110-8. doi: 10.1016/j.jcmg.2011.08.007.
Results Reference
derived

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Anti-Inflammatory Effects of Pioglitazone

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