MedDataX Logo

Anti-Inflammatory Effects of Pioglitazone

NCT ID: NCT00722631

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impaired Glucose Tolerance Type 2 Diabetes Mellitus Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pioglitazone

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

Intervention Type DRUG

Glimepiride

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CAS number: 111025-46-8, ATC code: A10BG03 CAS number: 93479-97-1, ATC code: A10BB12

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kurume University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nobuhiro Tahara

M.D., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nobuhiro Tahara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kurume University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kurume University Hospital

Kurume, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33210751 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31407236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24229770 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24030946 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21999871 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PIO 2007

Identifier Type: -

Identifier Source: org_study_id