UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000230 |
|---|---|
| Receipt number | 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 04:35:38 |
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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
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
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000230
