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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000230
Receipt No. R000000230
Scientific Title Effects of pioglitazone on coronary atherosclerotic plaques of patients with impaired glucose tolerance or type 2 diabetes mellitus:a randomized,open rabelled,prospective study.
Date of disclosure of the study information 2005/12/01
Last modified on 2010/09/14

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Basic information
Public title Effects of pioglitazone on coronary atherosclerotic plaques of patients with impaired glucose tolerance or type 2 diabetes mellitus:a randomized,open rabelled,prospective study.
Acronym Effects of pioglitazone on coronary atherosclerotic plaques:a randomized,open rabelled,prospective study of Pioglitazone Intervention on Coronary Atherosclerosis (PIGEON) using intravascular ultrasound.
Scientific Title Effects of pioglitazone on coronary atherosclerotic plaques of patients with impaired glucose tolerance or type 2 diabetes mellitus:a randomized,open rabelled,prospective study.
Scientific Title:Acronym Effects of pioglitazone on coronary atherosclerotic plaques:a randomized,open rabelled,prospective study of Pioglitazone Intervention on Coronary Atherosclerosis (PIGEON) using intravascular ultrasound.
Region
Japan

Condition
Condition Impaired glucose tolerance or type 2 diabetes mellitus with coronary artery disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate reduction and stabilization of coronary atherosclerotic plaques by pioglitazone.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Plaque volume,vessel volume,lumen volume and radiofrquency data assessed with intravascular ultrasound.
Plasma glucose,HbA1C,insulin,total cholesterol,triglyceride,LDL,HDL,MDA-LDL,8-isoprostane,MMP-9,MCP-1,PAI-1,TNF-a and hsCRP.
Major adverse cardiovascular event and harmful effect of pioglitazone
Key secondary outcomes Plasma GOT,GPT,T-BIL,CPK,ALP,G-GTP and LDH

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention group:Start to take pioglitazone 15mg per day after percutaneous coronary angioplasty and increase a dose to 30mg per day at 14days after angioplasty.And continue in 6 months.
Interventions/Control_2 Control group:Take no pioglitazone in 6 months after percutaneous coronary angioplasty.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patient who have impaired glucose tolerance or type 2 diabetes mellitus with undergoing percutaneous coronary angioplasty.
Key exclusion criteria Heart failure,acute myocardial infarction,severe hepatic or renal dysfunction,to take insulin,already to take pioglitazone,episode of adverse effect by troglitazone,pregnancy and severe hypercholesterolemia.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Issei Komuro
Organization Chiba University Graduate School of Medicine
Division name Division of cardiovascular science and medicine
Zip code
Address 1-8-1 Inohana,Chu-o ku,Chiba city,Chiba,JAPAN
TEL 043-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakayama
Organization Chiba University Graduate School of Medicine
Division name Division of cardiovascular science and medicine
Zip code
Address 1-8-1 Inohana,Chu-o ku,Chiba city,Chiba,JAPAN
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kimitsu Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Published: Nakayama T, Komiyama N, Yokoyama M, Namikawa S, Kuroda N, Kobayashi Y, Komuro I. Pioglitazone induces regression of coronary atherosclerotic plaques in patients with type 2 diabetes mellitus or impaired glucose tolerance: a randomized prospective study using intravascular ultrasound. Int J Cardiol. 2010;138(2):157-165. Epub 2008 Sep 24.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 03 Month 01 Day
Last follow-up date
2005 Year 12 Month 01 Day
Date of closure to data entry
2006 Year 08 Month 01 Day
Date trial data considered complete
2006 Year 08 Month 01 Day
Date analysis concluded
2006 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2010 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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